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Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.


An HIV Status-neutral Microeconomic Intervention 

Study Type: Interventional
Start Date: June 7, 2024
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Ruth Ellis Center, Highland Park, Michigan, United States

The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives:

To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color. The determine acceptability of the intervention with transgender women of color.


Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa 

Study Type: Interventional
Start Date: April 16, 2024
Eligibility: Females, 16 Years and Older, Accepts Healthy Volunteers
Location(s): TB HIV Care, Pietermaritzburg, KwaZulu Natal, South Africa

The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.


Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men 

Study Type: Interventional
Start Date: March 27, 2024
Eligibility: Males, 18 Years to 34 Years, Accepts Healthy Volunteers
Location(s): Emory University, Atlanta, Georgia, United States

The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are:

To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition Measure and assess secondary factors affecting app implementation Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups: Control: App access only Self-testing: App access + ability to order HIV and STI self-test kits Motivational interview: App access + motivational interview to develop plans to use app effectively. Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively.

Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups


Support for Adolescents Living With HIV in South Africa 

Study Type: Interventional
Start Date: February 2, 2024
Eligibility: 15 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): King Edward VIII Hospital, Congella, South Africa

This is a cluster randomized controlled trial determining the effectiveness of in-person or mHealth-based adolescent-friendly transition interventions compared to standard care on retention in care and viral suppression among adolescents living with HIV who have low transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in KwaZulu-Natal, South Africa.


Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities 

Study Type: Interventional
Start Date: February 2, 2024
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): University of Miami, Miami, Florida, United States

The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.


Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age 

Study Type: Interventional
Start Date: January 24, 2024
Eligibility: 2 Years to 11 Years, Does Not Accept Healthy Volunteers
Location(s): Site 12702, Molepolole CRS, Gaborone, Botswana; Site 5073, SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte, Brazil; CRS 31784, Chiang Mai University HIV Treatment CRS, Chiang Mai, Thailand; Site 5116, PHPT-Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Rai, Thailand; Site 5030, Emory University School of Medicine NICHD CRS, Atlanta, Georgia, United States; Site 6501, St. Jude Children's Research Hospital CRS, Memphis, Tennessee, United States; Site 12701, Gaborone CRS, Gaborone, Botswana

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age


One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project 

Study Type: Interventional
Start Date: January 1, 2024
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Kenya Medical Research Institute -KEMRI, Kisumu, Kenya

The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP. The investigators will evaluate data from men and women ≥15 years of age unknown to be living with HIV seeking PrEP services at public health facilities in western Kenya.


Inflammation and Depression in People With HIV 

Study Type: Interventional
Start Date: December 11, 2023
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Emory University Hospital, Atlanta, Georgia, United States; Grady Memorial Hospital, Atlanta, Georgia, United States

The purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 5 months.


Intervention for Virologic Suppression in Youth 

Study Type: Interventional
Start Date: November 29, 2023
Eligibility: 18 Years to 29 Years, Does Not Accept Healthy Volunteers
Location(s): Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), San Francisco, California, United States

The goal of this randomized clinical trial is to test the effect of a technology-based intervention with an Adaptive Treatment Strategy (ATS) among youth living with HIV (YLWH) (18-29 years old). This piloted and protocolized intervention combines: (1) brief weekly sessions with a counselor via a video-chat platform (video-counseling) to discuss mental health (MH), substance use (SU), HIV care engagement, and other barriers to care; and (2) a mobile health application (app) to address barriers such as ART forgetfulness and social isolation. Individuals who are not virologically suppressed will be randomized to video-counseling+app or standard of care (SOC). Through this study, the investigators will be able to:

Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH.The investigators will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT.

Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. The investigators will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT.

Aim 3: Explore an ATS to individualize the intervention by assigning the:

virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, virologic "responders" in the intervention arm to continue only app use for 16 more weeks.

Researchers will compare the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need to see if delivery of care is enhanced and impact on virologic suppression.


Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings 

Study Type: Interventional
Start Date: November 11, 2023
Eligibility: 15 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): Seke North CRS 30306, Harare, Zimbabwe; Harare Family Care CRS 31890, Harare, Zimbabwe; St. Mary's CRS 30303, Chitungwiza, Zimbabwe; Soweto IMPAACT CRS 8052, Soweto, South Africa; University of North Carolina Lilongwe CRS 12001, Lilongwe, Malawi; College of Medicine CRS 30301, Blantyre, Malawi; Molepolole Prevention/Treatment Trials CRS 12702, Molepolole, Botswana; Gaborone Prevention/Treatment Trials CRS 12701, Gaborone, Botswana

IMPAACT 2016 is a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The intervention is adapted to the local context through advance conduct of focus groups and pilot testing.


Rudi Kundini, Pamoja Kundini 

Study Type: Interventional
Start Date: October 23, 2023
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Katoro Health Center, Katoro, Tanzania; Geita Town Council Hospital, Geita, Tanzania

This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).


Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions 

Study Type: Interventional
Start Date: October 12, 2023
Eligibility: 18 Years to 100 Years, Does Not Accept Healthy Volunteers
Location(s): University of Central Florida, Orlando, Florida, United States

The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.


PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru 

Study Type: Interventional
Start Date: September 22, 2023
Eligibility: 15 Years to 23 Years, Does Not Accept Healthy Volunteers
Location(s): Instituto Nacional de Salud del Nino, Breña, Lima, Peru; Hospital Nacional Hipólito Unanue, Lima, Peru; Hospital Nacional Arzobispo Loayza, Lima, Peru; Hospital Nacional Daniel Alcides Carrión, Callao, Lima, Peru

This study is an evaluation of an intervention (nicknamed "PASEO") that aims to facilitate the transition to adult HIV care for adolescents living with HIV in Lima, Peru. The intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support.

The study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the PASEO intervention with regard to retention with viral load suppression as well as other indicators of well-being. The cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. The cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. Data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.


Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda 

Study Type: Interventional
Start Date: July 20, 2023
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Mbarara University of Science and Technology, Mbarara, Uganda

This study aims to test a new approach to support people living with Human Immunodeficiency Virus (HIV) in Uganda. Traditional healers (TH) will be trained to provide counselling and testing for HIV, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in HIV care. This support will be given in addition to the regular care provided at clinics. The main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.


1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV 

Study Type: Interventional
Start Date: June 26, 2023
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins School of Nursing, Baltimore, Maryland, United States

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (LWH) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV.

Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits).

Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.


Supporting Trans Affirmation, Relationships, and Sex, Phase 3 

Study Type: Interventional
Start Date: June 20, 2023
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Brown University, Providence, Rhode Island, United States

The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial.

There are several components to this research study:

First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test. If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys. Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being. Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program. This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours.

The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.


Baricitinib for Reduction of HIV - CNS 

Study Type: Interventional
Start Date: May 18, 2023
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Grady Memorial Hospital, Atlanta, Georgia, United States; Emory University Hospital, Atlanta, Georgia, United States

There is still no cure for the human immunodeficiency virus (HIV). While combination antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected individuals face a lifetime of treatment and many potential complications including end organ diseases such as HIV-associated neurocognitive disorders. HIV infection is controllable with antiretroviral therapy (ART), but ART cannot eliminate HIV reservoirs. Thus, there is no available cure for HIV. There is a large and growing body of evidence that the central nervous system (CNS) is an HIV reservoir site and a barrier to HIV eradication. Our group has done extensive pre-clinical work with janus-kinase (JAK 1/2) inhibitors. This includes baricitinib, which is an orally available, FDA-approved drug for rheumatoid arthritis. Evidence suggests that this drug has activity against HIV in the central nervous system (CNS). In our recently completed pilot study, we showed that baricitinib crosses the blood brain barrier (BBB) and decreases HIV CNS persistence in the brain.

Using bloodwork, neurocognitive testing, MRIs and lumbar punctures, we plan to evaluate the change in central nervous system HIV after treatment with baricitinib versus placebo. We will also evaluate changes in neuroimaging, inflammation in blood and cerebrospinal fluid (CSF), and neuropsychological performance after treatment with baricitinib versus placebo.

Evidence shows that the central nervous system is one of the reservoir sites that enables the HIV virus to persist in the body even after years of treatment. In order to attack this reservoir and eventually find a cure, it is vital to learn if certain medications can suppress HIV in the CNS.


SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy 

Study Type: Interventional
Start Date: May 17, 2023
Eligibility: 18 Years to 80 Years, Accepts Healthy Volunteers
Location(s): Yale School of Medicne, Neuro ID Research Program, New Haven, Connecticut, United States

The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers [11C]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET [11C]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).


Telehealth Delivery (Tele-B6) 

Study Type: Interventional
Start Date: April 18, 2023
Eligibility: Males, 18 Years to 29 Years, Does Not Accept Healthy Volunteers
Location(s): Grady Infectious Diseases Program Clinic, Atlanta, Georgia, United States

The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.


Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging 

Study Type: Interventional
Start Date: March 31, 2023
Eligibility: Males, 15 Years and Older, Accepts Healthy Volunteers
Location(s): Buffalo City Metro, East London, Eastern Cape, South Africa; Cape Town Metro, Cape Town, Western Cape, South Africa

This study will evaluate the impact of U=U messaging and counseling on gaps in the HIV care cascade for men, including testing uptake and ART initiation (Aim 1), achieving viral suppression and retention in care (Aim 2) in two provinces in South Africa. The U=U message communicates the compelling idea that PLHIV who take ART and have an undetectable viral load (<200 copies/mL) cannot sexually transmit HIV. Additionally, the investigators will conduct a multi-method evaluation to inform future implementation of U=U messaging interventions (Aim 3).


SEARCH SAPPHIRE Phase B 

Study Type: Interventional
Start Date: March 28, 2023
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Infectious Diseases Research Collaboration, Kampala, Uganda; SEARCH Office / GPRT, Kisumu, Kenya

This study will evaluate the effects of optimized dynamic prevention and treatment packages delivered in a precision community health model on HIV incidence, as well as other health outcomes, in a community randomized trial design.


Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV 

Study Type: Interventional
Start Date: March 3, 2023
Eligibility: 18 Years to 85 Years, Does Not Accept Healthy Volunteers
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States

This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.


SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth 

Study Type: Interventional
Start Date: March 1, 2023
Eligibility: 10 Years to 24 Years, Does Not Accept Healthy Volunteers
Location(s): Bugando Medical Centre, Mwanza, Tanzania; Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence, Mwanza, Tanzania; Mawenzi Regional Referral Hospital, Moshi, Tanzania; Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence, Mbeya, Tanzania; Chronic Disease Clinic of Ifakara Health Institute, Ifakara, Tanzania

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.


Youth Ending the HIV Epidemic 

Study Type: Interventional
Start Date: January 31, 2023
Eligibility: 18 Years to 29 Years, Does Not Accept Healthy Volunteers
Location(s): UCSF Center for AIDS Prevention Studies, San Francisco, California, United States

Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, an increased risk of antiretroviral therapy (ART) nonadherence and virologic failure, and a high probability of disease progression and transmission. Tracking and monitoring objective measures of ART adherence in real time is critical to strategies to support adherence and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires extra effort from providers to understand adherence patterns, making it difficult for providers to accurately determine how to support their patients in real time. In the proposed interventional study, the investigators aim to pilot test an automated directly observed therapy intervention paired with conditional economic incentives to improve ART adherence among youth living with HIV (YLWH) (18-29 years-old) who have an unsuppressed HIV viral load.

Aim 1: Conduct a pilot study to assess feasibility and acceptability of the use of automated directly observed therapy with conditional economic incentives (aDOT-CEI) among YLWH (aged 18-29; N= 30) at AIDS Healthcare Foundation (AHF) clinics in California and Florida. Primary outcomes will be feasibility and acceptability, assessed using predefined feasibility metrics and acceptability surveys at three months.

Aim 2: Explore experiences of YLWH and staff/providers with the aDOT-CEI intervention and implementation facilitators and barriers. The investigators will conduct in-depth qualitative interviews with a sample of YLWH from Aim 1 and staff/providers purposively selected from participating AHF clinics to explore intervention experiences, potential influences on ART adherence, individual-level and clinic-level barriers and facilitators to intervention implementation, and suggested refinements for a future efficacy trial.

The investigators hypothesize that the aDOT-CEI intervention to improve ART adherence among YLWH will have high feasibility and acceptability.


HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV 

Study Type: Interventional
Start Date: January 15, 2023
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Infectious Diseases Institute, Makerere University, Kampala, Uganda

This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.


PositiveLinks: mHealth for DC Cohort 

Study Type: Interventional
Start Date: December 12, 2022
Eligibility: 16 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Georgetown University, Washington, District of Columbia, United States; MetroHealth, Washington, District of Columbia, United States; Unity Medical Center, Washington, District of Columbia, United States; La Clinica Del Pueblo, Washington, District of Columbia, United States; Medstar Washington Hospital Center, Washington, District of Columbia, United States; Washington Health Institute, Washington, District of Columbia, United States; Family and Medical Counseling Service, Washington, District of Columbia, United States; Whitman-Walker Health, Washington, District of Columbia, United States; George Washington Medical Faculty Associates, Washington, District of Columbia, United States; Howard University Hospital Adult Clinic, Washington, District of Columbia, United States; Howard University Hospital Pediatric Clinic, Washington, District of Columbia, United States

To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.


Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth 

Study Type: Interventional
Start Date: November 23, 2022
Eligibility: 14 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): International Center for Child Health and Development (ICHAD), Masaka, Uganda

The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.


Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement 

Study Type: Interventional
Start Date: November 15, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): The Regents of the Univ. of Calif., U.C. San Diego, La Jolla, California, United States

A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).


A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 

Study Type: Interventional
Start Date: October 5, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Bronx-Lebanon Hospital Center NICHD CRS, Bronx, New York, United States; Rush University, Cook County Hospital NICHD CRS, Chicago, Illinois, United States; University of Colorado Denver NICHD CRS, Aurora, Colorado, United States; Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Rai, Thailand; Umlazi, Durban, Kwa Zulu Natal, South Africa; Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa

This study will test an anti-HIV drug (ARV) for newborn babies. The study will include a minimum of 36 and up to 108 mothers living with HIV and their newborn babies from Brazil, South Africa, Thailand, and the United States. Infants will be in the study for approximately 16 weeks (four months) after they are born. Mothers will not receive study drug and will exit the study after the Entry visit.


Clinic-based HIV Identification and Prevention Project Using Electronic Resources 

Study Type: Interventional
Start Date: October 3, 2022
Eligibility: Females, 15 Years to 65 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Health System, Baltimore, Maryland, United States

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.


Case Management Dyad 

Study Type: Interventional
Start Date: September 9, 2022
Eligibility: 18 Years to 40 Years, Accepts Healthy Volunteers
Location(s): University of Chicago, Chicago, Illinois, United States

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.


Suubi+Adherence4Youth 

Study Type: Interventional
Start Date: September 1, 2022
Eligibility: 11 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): International Center for Child Health and Development, Masaka, Uganda

The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression.

The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.


Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT) 

Study Type: Interventional
Start Date: August 30, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Miami, Miami, Florida, United States

The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.


AmbassADDOrs for Health Study 

Study Type: Interventional
Start Date: July 26, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Mwanza Province, Mwanza, Tanzania

The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.


CPT-L to Improve Outcomes for Individuals With HIV and PTSD 

Study Type: Interventional
Start Date: July 13, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Medical University of South Carolina, Charleston, South Carolina, United States

This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.


Pharmacy-based Pre-exposure Prophylaxis 

Study Type: Interventional
Start Date: May 19, 2022
Eligibility: Males, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Emory University, Atlanta, Georgia, United States

The proposed research will develop a culturally appropriate pharmacy PrEP delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.


Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care 

Study Type: Interventional
Start Date: April 26, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Malvern Clinic, Johannesburg, Gauteng, South Africa

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).


Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM 

Study Type: Interventional
Start Date: April 1, 2022
Eligibility: Males, 15 Years to 24 Years, Accepts Healthy Volunteers
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States

This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.


M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma 

Study Type: Interventional
Start Date: March 15, 2022
Eligibility: 10 Years to 17 Years, Accepts Healthy Volunteers
Location(s): International Center for Child Health and Development Field Office, Masaka, Uganda

M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms


Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya 

Study Type: Interventional
Start Date: February 24, 2022
Eligibility: Females, 16 Years to 24 Years, Accepts Healthy Volunteers
Location(s): Partners in Health and Research Development, Thika, Kenya

Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: peer PrEP referral + HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to informal word-of-month peer PrEP referral (currently ongoing in Kenya), formalized peer PrEP referral + HIVST delivery will increase PrEP adoption (i.e., initiation, retention, and adherence) among peers, and be low cost and have high fidelity in Kenya.


Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men 

Study Type: Interventional
Start Date: February 23, 2022
Eligibility: Males, 16 Years to 25 Years, Accepts Healthy Volunteers
Location(s): Institute of HIV Research and Innovation, Bangkok, Thailand; Rainbow Sky Association of Thailand, Bangkok, Thailand; SWING Foundation, Bangkok, Thailand

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).


Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV 

Study Type: Observational
Start Date: February 2, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site, Kericho, Kenya; Harare Family Care (31890), Harare, Zimbabwe; St. Mary's CRS 30303, Chitungwiza, Zimbabwe; Seke North CRS 30306, Chitungwiza, Zimbabwe; 31798, Baylor-Uganda Clinical Research Site, Kampala, Uganda; Siriraj Hospital Mahidol University CRS (5115), Bangkok, Ratchathewi, Thailand; Family Clinical Research Unit (FAM-CRU) CRS (8950), Tygerberg Hills, South Africa; 8051, Wits RHI Shandukani Research Centre Clinical Research Site, Johannesburg, South Africa; 30300, Umlazi Clinical Research Site, Durban, South Africa; Soweto IMPAACT CRS (8052), Johannesburg, Gauteng, South Africa; University of North Carolina Lilongwe (12001), Lilongwe, Malawi; College of Med. JHU CRS (30301), Blantyre, Malawi; Ribeirao Preto Medical School, University of Sao Paulo (5074), Sao Paulo, Brazil; Hospital Geral De Nova Igaucu (5097), Rio de Janeiro, Brazil; Hospital dos Servidores Rio de Janeiro, Rio De Janeiro, Brazil; School of Medicine, University of Minas Gerais - FUNDEP (5073), Belo Horizonte, Brazil; 5128, Texas Children's Hospital Clinical Research Site, Houston, Texas, United States; 5030, Emory University School of Medicine Clinical Research Site, Atlanta, Georgia, United States; Univ of Miami Pediatric/Perinatal HIV/AIDS (5127), Miami, Florida, United States; 5055, South Florida CDTC Fort Lauderdale Clinical Research Site, Fort Lauderdale, Florida, United States; University California, San Diego (CRS 4601), San Diego, California, United States; David Geffen School of Medicine at UCLA (CRS 5112), Los Angeles, California, United States

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.


Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women 

Study Type: Interventional
Start Date: February 2, 2022
Eligibility: Females, 15 Years to 59 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Bloomberg School of Public Health, Houston, Texas, United States; Johns Hopkins Bloomberg School of Public Health, Dallas, Texas, United States; Johns Hopkins Bloomberg School of Public Health, Austin, Texas, United States; Johns Hopkins Bloomberg School of Public Health, San Antonio, Texas, United States

The proposed intervention is a web-based intervention guided by theoretical components to increase HIV home testing among Black women at risk for HIV and sexually transmitted infections (STIs) in a HIV hotspot in the South. The intervention will promote using the home test, linkage to care, and linkage to pre-exposure prophylaxis (PrEP) evaluation. The intervention has the potential to be implemented on a large scale and tailored based on location and population to increase testing, treatment, and PrEP adoption.


Developing a Trauma-focused Intervention for Older Adults Living With HIV 

Study Type: Interventional
Start Date: January 18, 2022
Eligibility: 50 Years to 85 Years, Does Not Accept Healthy Volunteers
Location(s): University of South Carolina, Columbia, South Carolina, United States

Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.


Peer-driven Intervention on PrEP 

Study Type: Interventional
Start Date: January 6, 2022
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): The Miriam Hospital, Providence, Rhode Island, United States

The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.


Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya 

Study Type: Interventional
Start Date: January 1, 2022
Eligibility: Females, 15 Years to 100 Years, Accepts Healthy Volunteers
Location(s): Ober Health Center, Homa Bay, Kenya

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.


The SMART ART Study 

Study Type: Interventional
Start Date: November 2, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Human Sciences Research Council Sweetwaters, Sweetwaters, Kwa-zulu Natal, South Africa

The investigators propose A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa- the SMART ART study-a randomized study to test adaptive ART delivery for persons with detectable viral load and/or not engaged in care.The types of differentiated service delivery (DSD) that will be examined in this study are incentives, community-based ART, and home delivery. The study plans to enroll up to 900 participants-people living with HIV and who are eligible for ART and living in KwaZulu-Natal, South Africa. The study aims to maximize the proportion of ART eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery, and evaluate the cost effectiveness of adaptive HIV treatment for those who are not engaged in care.


Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum 

Study Type: Observational
Start Date: September 1, 2021
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Famcru Crs, Tygerberg Hills, South Africa; Baylor-Uganda CRS, Kampala, Uganda; Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116), Chiang Rai, Thailand; Siriraj Hospital, Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand; Sizwe CRS, Johannesburg, South Africa; Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town, South Africa; Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa; IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico; Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS, Kericho, Kenya; Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, Maharashtra, India; Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio De Janeiro, Brazil; Hospital Federal dos Servidores do Estado NICHD CRS, Rio De Janeiro, Brazil; SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte, Brazil; Univ. of Sao Paulo Brazil NICHD CRS (Site ID: 5074), Ribeirão Preto, São Paulo, Brazil; Gaborone CRS (Site ID: 12701), Gaborone, South-East District, Botswana; Molepolole CRS (Site ID: 12702), Molepolole, Kweneng District, Botswana; Baylor College of Medicine/ Texas Children's Hospital NICHD CRS (Site ID: 5128), Houston, Texas, United States; St. Jude Children's Research Hospital CRS, Memphis, Tennessee, United States; SUNY Stony Brook NICHD CRS, Stony Brook, New York, United States; Jacobi Med. Ctr. Bronx NICHD CRS, Bronx, New York, United States; Bronx-Lebanon Hospital Center NICHD CRS, Bronx, New York, United States; Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore, Maryland, United States; Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001), Chicago, Illinois, United States; Rush University Cook County Hospital Chicago NICHD CRS, Chicago, Illinois, United States; Emory University School of Medicine NICHD CRS, Atlanta, Georgia, United States; Pediatric Perinatal HIV NICHD CRS, Miami, Florida, United States; University of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States; South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, United States; Univ. of Colorado Denver NICHD CRS, Aurora, Colorado, United States; University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, San Diego, California, United States; David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles, California, United States; Usc La Nichd Crs, Los Angeles, California, United States

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.


PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya 

Study Type: Interventional
Start Date: March 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Kenyatta National Hospital, Kisumu, Kenya

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.


A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa 

Study Type: Interventional
Start Date: February 18, 2021
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Cape Town, Cape Town, South Africa

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.


Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients 

Study Type: Interventional
Start Date: December 21, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Brown University, Providence, Rhode Island, United States

The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.

The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.


Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care 

Study Type: Interventional
Start Date: September 3, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Fenway Health, Boston, Massachusetts, United States; University of Miami, Miami, Florida, United States

The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.


HIV Treatment Adherence Dose Determination Trial 

Study Type: Interventional
Start Date: September 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Connecticut Field Site, Atlanta, Georgia, United States; University of Connecticut, Storrs, Connecticut, United States

The proposed research will conduct the first dose-determination trial to find the optimal number of behavioral counseling sessions (dose) needed to achieve and sustain optimal HIV treatment adherence. The results of this study will determine how much intervention is needed for whom and at what cost to guide health policy and implementation of behavioral interventions designed to improve durable viral suppression.


Biomedical HIV/AIDS Prevention Program Yunnan 

Study Type: Interventional
Start Date: August 1, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Yunnan Center for Disease Prevention and Control, Kunming, Yunnan, China

B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.


An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM 

Study Type: Interventional
Start Date: March 4, 2020
Eligibility: Males, 18 Years to 34 Years, Does Not Accept Healthy Volunteers
Location(s): University of Illinois at Chicago, Chicago, Illinois, United States

The investigators propose to determine the efficacy of "My Personal Health Guide," a theory-based innovative talking relational human Avatar mobile phone application to engage HIV-positive AAMSM in adherence and retention in care. Providing an empathetic talking Avatar source of HIV-related information, motivation, and behavioral skills that is as private and convenient as their own mobile phone might produce a high impact by overcoming barriers to HIV adherence and retention in care such as stigma and health literacy.


Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite 

Study Type: Observational
Start Date: November 1, 2017
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Seattle Children's Hospital, Seattle, Washington, United States; Rush University Cook County Hospital Chicago, Chicago, Illinois, United States; Emory University School of Medicine, Atlanta, Georgia, United States; David Geffen School of Medicine at UCLA, Los Angeles, California, United States; University of Southern California, Los Angeles, California, United States; Boston Medical Center, Boston, Massachusetts, United States; New York University School of Medicine, New York, New York, United States; SUNY Stony Brook, Stony Brook, New York, United States; Johns Hopkins University, Baltimore, Maryland, United States

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.


Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission 

Study Type: Interventional
Start Date: January 23, 2015
Eligibility: 48 Hours and Younger, Does Not Accept Healthy Volunteers
Location(s): 4601, University of California, San Diego Clinical Research Site, La Jolla, California, United States; 6501, St Jude Children's Research Hospital Clinical Research Site, Memphis, Tennessee, United States; 5013, Jacobi Medical Center Clinical Research Site, Bronx, New York, United States; 5114, Bronx Lebanon Hospital Center Clinical Research Site, Bronx, New York, United States; 5092, Johns Hopkins Clinical Research Site, Baltimore, Maryland, United States; 4001, Lurie Children's Hospital of Chicago Clinical Research Site, Chicago, Illinois, United States; 5083, Rush University Cook County Hospital Clinical Research Site, Chicago, Illinois, United States; 5127, Pediatric Perinatal HIV Clinical Research Site, Miami, Florida, United States; 5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site, Jacksonville, Florida, United States; 5055, South Florida CDTC Fort Lauderdale Clinical Research Site, Fort Lauderdale, Florida, United States; 31798, Baylor-Uganda Clinical Research Site, Kampala, Uganda; 5116, Chiangrai Prachanukroh Hospital Clinical Research Site, Chiang Mai, Thailand; 5115, Siriraj Hospital Mahidol University Clinical Research Site, Bankok, Bangkoknoi, Thailand; 5118, Kilimanjaro Christian Medical Centre Clinical Research Site, Moshi, Tanzania; 8950, FAMCRU Clinical Research Site, Tygerberg, Western Cape, South Africa; 30300, Umlazi Clinical Research Site, Durban, Kwa Zulu Natal, South Africa; 5129, University of Puerto Rico Gamma Project Clinical Research Site, San Juan, Puerto Rico; 30301, Blantyre Clinical Research Site, Blantyre, Malawi; 12001, Malawi Clinical Research Site, Lilongwe, Central, Malawi; 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site, Kericho, Kenya; 30022, Les Centres GHESKIO Clinical Research Site, Port-au-Prince, Haiti; 5074, University of Sao Paulo Clinical Research Site, São Paulo, Brazil; 5097, Hospital Geral de Nova Igaucu Clinical Research Site, Rio De Janeiro, Brazil; 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site, Rio De Janeiro, Brazil; 5073, School of Medicine Federal University Minas Gerais Clinical Research Site, Minas Gerais, Brazil; 5052, University of Colorado, Denver Clinical Research Site, Aurora, Colorado, United States; 5112, David Geffen School of Medicine at UCLA Clinical Research Site, Los Angeles, California, United States; 5048, University of Southern California Clinical Research Site, Los Angeles, California, United States; 31890, Harare Family Care Clinical Research Site, Harare, Zimbabwe; 30306, Seke North Clinical Research Site, Chitungwiza, Zimbabwe; 30303, Saint Mary's Clinical Research Site, Chitungwiza, Zimbabwe; 5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site, Houston, Texas, United States

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.


Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up) 

Study Type: Observational
Start Date: April 30, 2014
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Baylor College of Medicine, Houston, Texas, United States; San Juan Research Hospital, San Juan, Puerto Rico; St. Jude Children's Research Hospital, Memphis, Tennessee, United States; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States; Jacobi Medical Center, Bronx, New York, United States; Bronx Lebanon Hospital Center, Bronx, New York, United States; Rutgers - New Jersey Medical School, Newark, New Jersey, United States; Children's Hospital Boston, Boston, Massachusetts, United States; Tulane University Health Sciences Center, New Orleans, Louisiana, United States; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, United States; University of Miami, Miami, Florida, United States; Children's Diagnostic and Treatment Center, Fort Lauderdale, Florida, United States; University of Colorado Denver Health Sciences Center, Aurora, Colorado, United States; University of California San Diego, La Jolla, California, United States

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.