HIV/AIDS

The goal of this observational study is to learn about the pilot test of the employment program among young Black sexual minority men.

The main question it aims to answer is: What is the feasibility and acceptability of the employment program?

Young Black sexual minority male participants will attend the two day employment program and will complete four study surveys over the course of 13 months.

Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.

To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.

The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are:

1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM. 2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence. 3. Describe the acceptability and feasibility of C4 implementation in community settings.

Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.

The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV/STI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.

The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.

This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai, young transgender women (18-29 years).

The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston/Harris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).

This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.

Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.

The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The evaluation will apply use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations of interventions. The impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in analysis.

The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.

human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely.

While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries.

This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.

The overarching goal of this study is to implement both a transition community adherence club strategy (Group-SPARCS) and an ART provision strategy (ART-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The current proposal will allow for a fully powered effectiveness randomized clinical trial (RCT).

* To compare the effectiveness of Full-SPARCS, ART-SPARCS, and Group-SPARCS to care as usual and to each other to achieve HIV RNA suppression 6 months following correctional facility release * To assess determinants of implementation of Full-SPARCS, ART-SPARCS, and Group-SPARCS. * To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS, ART-SPARCS, and Group-SPARCS.

In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. We will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. We will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, we will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. We will work with the cancer ward at the hospital to implement these strategies. Finally, we will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. We will measure acceptability of these strategies to both patients and hospital staff. We will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. We will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.

Although there have been advances in antiretroviral treatment (ART) for HIV, adolescents and young adults living with HIV (AHIV) continue to have disparate HIV outcomes particularly viral suppression (VS), when compared to other populations likely related to multi-layered challenges (social determinants, cognitive development), system, and biomedical challenges including the reliance on oral ART as the only choice for HIV treatment. Given that approximately 1/3 of AHIV despite being in care fail to attain or sustain VS with resultant individual and public health risk, there is a need to develop real-world implementable interventions that can improve the participants virologic outcomes. The Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study aims to 1) optimize personal ART choice by using the HIV-ASSIST clinical program to inform CHOICE counseling regarding an AHIV's preferred approach, including the possibility of long-acting injectable ART (LAI-ART); 2) facilitate access to the participants preferred choice through deploying a focused team to navigate barriers to attaining LAI-ART; and 3) decipher and address the patient, provider, and systemic barriers to the uptake and routinization of LAI-ART among AHIV by applying an implementation science framework and assessing cost-effectiveness providing critical data to support comprehensive approaches to optimizing ART and VS for AHIV, a key population identified in the Ending the HIV Epidemic in the United States Initiative.

The objective of this study is to evaluate the JUNTOS Referral Network as an implementation strategy to enhance the reach of HIV-prevention and treatment services to Latino gay, bisexual, and other men who have sex with men (MSM).

Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life.

The purpose of this study is to pilot an adapted resiliency-based mind-body intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for people with HIV (PWH) in the public sector in South Africa (SA). In Phase 1 \[NIH Grant Number: R34MH131426; Human Research Ethics Committee (HREC) Ethics Reference Number: 220813\], the investigators conducted focus group discussions to solicit feedback on: the role of culture and perceptions of stress; the lived experiences of stress; sources of stress (e.g. occupational, trauma related); how stress impacts job functioning (specifically patient care); current coping strategies; and the intervention modules (content, number of sessions, session duration, program length, mode of delivery (e.g., virtual, in-person, hybrid approaches, use of coaches), etc.). In this phase 2, the investigators will conduct a small proof-of-concept study (N = 8-10), followed by a randomized pilot (N = 60) of nurses that care for PWH in the public sector in South Africa (SA) to test the feasibility and acceptability of the adapted intervention.

The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for Black/African American (B/AA) men who have sex with men (MSM) on PrEP initiation, adherence and retention in care. B/AA men who have sex with men (MSM) are disproportionately impacted by the HIV/AIDS epidemic in the United States. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care among B/AA MSM. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young B/AA MSM. The intervention was found to be highly acceptable among B/AA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits. Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among B/AA MSM in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among B/AA MSM attending CHCs compared to standard of care. The investigators will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1. Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence for B/AA MSM which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence among B/AA MSM, which aligns with federal Ending the HIV Epidemic and National HIV/AIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV, PrEP and disparities research in real-world clinical settings.

This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system.

The main question it aims to answer is:

• Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community?

Participants on the study will be:

* Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.

This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).

This pilot research study will provide timely access to behavioral health services through the provision of a single-session narrative therapy intervention. The goal of this 6-month study is to test the acceptability, feasibility, and fit of the intervention in an integrated primary care clinic serving people living with HIV.

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

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.

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.

The impact of effective HIV prevention tools is limited because many people do not know that they are at risk for HIV acquisition, despite the availability of various risk assessment scores and criteria. This proposal aims to use a novel data science approach to assessing HIV prevention needs among 400 young women in Kisumu, Kenya- namely, topic modeling and network analysis of text and/or social media messages (e.g., WhatsApp, Instagram, Twitter). The study will involve in-depth assessment of relevant ethical and logistical factors to ensure appropriate and optimized use of a sentiment analysis tool for implementation in routine clinical care.

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

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.

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.

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 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:

1. virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, 2. 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.

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.

This study seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among sexual and gender minority (SGM) young people living with HIV (ages 18-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence.

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.

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.

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) 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.

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.

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).

This study will evaluate the impact of Family Connections, a family-based group intervention for adolescents and young adults (AYA) living with HIV and their family caregivers, on achieving HIV self-management defined as having an undetectable viral load (VL) and low self-stigma (a score of 1 or less), among older adolescents and young adults (AYA) ages 15-to-21 years. The intervention seeks to increase social and family support and decrease self-stigma among AYA, so they may improve their medication adherence and achieve an undetectable viral load. Findings will fill a critical gap in available evidence-based intervention options for improving the HIV-related outcomes and wellbeing of HIV-positive AYA in sub-Saharan 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).

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.

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.

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.

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.

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).

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.

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.

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.

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.

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).

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.

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.

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

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.

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.

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.

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.