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Transforming the understanding
and treatment of mental illnesses.

Featured Studies

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


MyPEEPS Mobile for Young Transgender Men

Study Type: Interventional
Start Date: June 30, 2023
Eligibility: Females, 15 Years to 19 Years, Accepts Healthy Volunteers
Location(s): Ann & Robert H. Lurie Children's Hospital Chicago, Chicago, Illinois, United States; Callen-Lorde Community Health Center, New York, New York, United States; Columbia University, New York, New York, United States

Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes, including high vulnerability to HIV and other sexually transmitted infections. The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.


AmbassADDOrs for Health Study

Study Type: Interventional
Start Date: August 10, 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.


Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

Study Type: Interventional
Start Date: July 20, 2022
Eligibility: Females, 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Virginia Commonwealth University, Richmond, Virginia, United States

The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.


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.


Clinical Decision Support for PrEP

Study Type: Interventional
Start Date: July 11, 2022
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Saban Community Clinic, Los Angeles, California, United States; Roanoke Chowan Community Health Center, Ahoskie, North Carolina, United States; Kintegra Health, Gastonia, North Carolina, United States

Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.


Traditional Healer-initiated HIV Counseling and Testing in South Africa

Study Type: Interventional
Start Date: July 7, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Thulamahashe Health Facility, Thulamahashi, Mpumalanga, South Africa

The objective of this proposal is to conduct a pilot test of a program aimed at training traditional healers to conduct HIV testing and implementing HIV testing among people living in Bushbuckridge, South Africa.

Pilot Healer-initiated HIV testing uptake and linkage to prevention services. Trust in allopathic health care and HIV stigma will be measured among participants at study enrollment and at month seven.

Hypothesis: Healer-initiated HIV counseling and testing (HICT) will increase trust in allopathic health care and reduce HIV stigma.


Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV

Study Type: Interventional
Start Date: June 21, 2022
Eligibility: 15 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): University of Cape Town, Cape Town, South Africa

The overall goal of this pilot randomized-controlled trial (RCT) is to pilot MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app with 50 adolescents living with HIV to assess its feasibility and acceptability and to explore preliminary effects on ART adherence and social support.


Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Study Type: Interventional
Start Date: June 15, 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.


Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa

Study Type: Interventional
Start Date: June 8, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): South African Medical Research Council, Cape Town, Western Cape, South Africa

Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up (LTFU) in HIV/TB care. Patients with depression and substance use (SU) have a greater likelihood of being LTFU in HIV/TB care, and there is evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, this purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana"). The purpose of this training is to provide CHWs with psychoeducation, skills, and support around working with HIV/TB patients with depression/SU. The investigators will assess the training's implementation and changes in CHWs' stigma towards HIV/TB patients with depression/SU.


Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)

Study Type: Interventional
Start Date: May 20, 2022
Eligibility: 14 Years and Older, Accepts Healthy Volunteers
Location(s): Infectious Disease Institute, Kampala, Uganda

It is critical to evaluate strategies that leverage women's engagement in antenatal care to increase male partner testing while alleviating the burden on pregnant women to encourage their male partners to HIV test. A peer-delivered status-neutral approach to male partners of pregnant women may be an innovative strategy to overcome barriers to men's reluctance to test for HIV and initiate HIV prevention or treatment services. For pregnant women living with HIV, partner testing and disclosure could facilitate women's continuation of ART post-partum, and for HIV-negative women at risk of HIV acquisition, this could facilitate women's initiation of PrEP during pregnancy. Thus, multiple public health goals could be achieved through increasing the proportion of men who know their HIV status.


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).


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


Supporting Sustained HIV Treatment Adherence After Initiation

Study Type: Interventional
Start Date: March 9, 2022
Eligibility: 16 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Weltevreden Valley, Cape Town, Western Cape, South Africa; Phumlani, Cape Town, Western Cape, South Africa; Mzamomhle, Cape Town, Western Cape, South Africa

The investigators will implement a 24-month fractional factorial design study (Aim 1). The investigators will recruit 510 patients initiating antiretroviral therapy (ART) at three City of Cape Town ART clinics. Each patient will have adherence monitored using the Wisepill® electronic adherence monitoring device (EAM). After eligibility has been confirmed, each participant will be randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence, with increasing degrees of sophistication, with immediate linkage to adherence support. Two components focus on supporting good adherence. They both supplement the existing adherence support program delivered at the study clinics operated by City of Cape Town (standard of care component). Based on Self-Determination Theory, the investigators postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. A subset of the participants, as well as clinic staff, will be invited to in-depth interviews to explore mediating factors (Aim 1) and the implementation process (Aim 2); and the data collected in Aims 1 and 2 will be used to explore cost effectiveness (Aim 3).


TAKE Steps: Motivational Interviewing to Prevent STIs

Study Type: Interventional
Start Date: March 7, 2022
Eligibility: 13 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): CHOP Primary Care, Cobbs Creek, Philadelphia, Pennsylvania, United States; CHOP Karabots Pediatric Care Center, West Philadelphia, Philadelphia, Pennsylvania, United States

This study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (STIs). The sessions will provide HIV/STI prevention education, use motivational interviewing (MI) to enhance goal setting, and providing skill building and referral to evidence based STI and HIV prevention strategies Pre-Exposure Prophylaxis (PrEP), condom use, and partner notification.


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): Rainbow Sky Association of Thailand, Bangkok, Thailand; Institute of HIV Research and Innovation, 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).


Mobile HIV Prevention App for Black Women

Study Type: Interventional
Start Date: February 5, 2022
Eligibility: Females, 18 Years to 44 Years, Accepts Healthy Volunteers
Location(s): Center for Black Women's Wellness, Atlanta, Georgia, United States

Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts.

The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.


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): David Geffen School of Medicine at UCLA (CRS 5112), Los Angeles, California, United States; 3801, Texas Children's Hospital Clinical Research Site, Houston, Texas, United States; Univ of Miami Pediatric/Perinatal HIV/AIDS (4201), Miami, Florida, 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.


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.


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.


Addressing the Continuum of Care Among High-risk Thai Men

Study Type: Interventional
Start Date: November 27, 2021
Eligibility: Males, 15 Years to 29 Years, Accepts Healthy Volunteers
Location(s): M-Health Office Ubon, Ubon Ratchathani, Thailand; M-Health Office Maha Sarakham, Maha Sarakham, Thailand

Young Thai men who have sex with men (YMSM) are at high risk for HIV. However, the Thailand National HIV Strategy does not adequately cover HIV prevention for YMSM using specific methods relevant to them, and instead uses a one-size-fits all approach. Partnering with the Thailand Ministry of Public Health (MOPH), the proposed study seeks to finalize, implement and evaluate a multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire Continuum of Prevention and Care. The investigators propose to test the efficacy of this approach by conducting research in two Northeastern Thai cities, one randomized to the intervention condition, which will receive HUG-M+ and the other to the control condition, where standard of care will be provided. If HUG-M+ is found to be efficacious, it might be scaled up, with the support of the MOPH, to other regions in Thailand, elsewhere in Asia and the US.


Parrying the Pitfalls of PrEP: Project PEACH

Study Type: Interventional
Start Date: November 20, 2021
Eligibility: Males, 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): PRISM Research Center, Atlanta, Georgia, United States

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.


Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa

Study Type: Interventional
Start Date: November 12, 2021
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): HIV Clinic, Johannesburg, Gauteng, South Africa

This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.


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.


Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness

Study Type: Interventional
Start Date: November 1, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Utale Health Centres, Balaka, Malawi; Chikweo Health Centre, Machinga, Malawi; Gawanani Health Centre, Machinga, Malawi; Kawinga Dispensary, Machinga, Malawi; Machinga District Hospital, Machinga, Malawi; Mahinga Health Centre, Machinga, Malawi; Mangamba Health Centre, Machinga, Malawi; Mbonechela Dispensary, Machinga, Malawi; Mkwepere Health Centre, Machinga, Malawi; Mpiri Health Centre, Machinga, Malawi; Mposa Health Centre, Machinga, Malawi; Namandanje Health Centre, Machinga, Malawi; Namanja Health Centre, Machinga, Malawi; Nayinunje Health Centre, Machinga, Malawi; Nayuchi Health Centre, Machinga, Malawi; Ngokwe health Centre, Machinga, Malawi; Nsanama Health Centre, Machinga, Malawi; Ntaja Health Centre, Machinga, Malawi; Namanolo Health Centre, Balaka, Malawi; Namdumbo Health Centre, Balaka, Malawi; Phalula Health Centre, Balaka, Malawi; Phimbi Health Centre, Balaka, Malawi; Ulongwe Health Centre, Balaka, Malawi; Chamba Dispensary, Machinga, Malawi; Nthorowa Health Centre, Machinga, Malawi; Nyambi Health Centre, Machinga, Malawi; Balaka District Hospital, Balaka, Malawi; Balaka OPD Health Centre, Balaka, Malawi; Chiendausiku Health Centre, Balaka, Malawi; Kalembo Health Centre, Balaka, Malawi; Kankao Health Centre, Balaka, Malawi; Kwitanda Health Centre, Balaka, Malawi; Mbera Health Centre, Balaka, Malawi

Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.


Interrupting HIV and TB Stigma in the Household in Uganda

Study Type: Interventional
Start Date: October 25, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Makerere University, Kampala, Uganda

The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in the household and increase diagnosis of HIV.


Peer-driven Intervention on PrEP

Study Type: Interventional
Start Date: October 8, 2021
Eligibility: Males, 18 Years to 100 Years, Accepts Healthy Volunteers
Location(s): The Miriam Hospital, Providence, Rhode Island, United States

The objective of this study is to seek knowledge of components of an effective peer-driven intervention (PDI) approach assess the feasibility and efficacy of a PDI on PrEP uptake for the purpose of expanding this PDI to promote PrEP in a large scale study.


LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care

Study Type: Interventional
Start Date: September 14, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): UCSD AntiViral Research Center, San Diego, California, United States

Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. The study will be conducted in 2 phases with corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 2), investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.


Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV

Study Type: Interventional
Start Date: August 1, 2021
Eligibility: Males, 18 Years to 99 Years, Does Not Accept Healthy Volunteers
Location(s): Guangzhou Center for Diseases Control and Prevention, Guangzhou, Guangdong, China

Individuals will participate in a pilot randomized controlled trial (RCT) that implements and evaluates the feasibility, acceptability, and effectiveness of crowdsourced partner services (PS) or conventional PS among Chinese men who have sex with men (MSM) living with HIV.

The pilot RCT will include 120 newly identified MSM HIV cases who were born biologically male, aged 18 years old or older, newly identified as HIV positive, had oral or anal sex with a man, had at least one sexual partner in the previous 6 months and live in Guangzhou. Participants will undergo a series of computer-based interviews (baseline and 2 months after enrollment) and will be randomly assigned into two groups in 2:1 ratio (intervention: control) and receive crowdsourced PS and conventional PS, respectively.


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

Study Type: Interventional
Start Date: June 8, 2021
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico; Rush University Cook County Hospital Chicago NICHD CRS, Chicago, Illinois, United States; University of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States; South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, United States; Usc La Nichd Crs, Los Angeles, California, United States; Siriraj Hospital, Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand; Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa

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.


PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Study Type: Interventional
Start Date: May 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Ober Health Center, Homa Bay, Kenya; Masogo Sub-County Hospital, Kisumu, Kenya; Nyahera Sub Sub County Hospital, Kisumu, Kenya; Bondo County Referral Hospital, Siaya, Kenya; Kendu Sub-District Hospital, Homa Bay, Kenya; Uyawi Sub County Hospital, Siaya, Kenya; Malanga Health Center, Siaya, Kenya; Madiany Sub County Hospital, Siaya, Kenya

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


InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media

Study Type: Interventional
Start Date: April 15, 2021
Eligibility: 15 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): University of Kwazulu-Natal, Westville, South Africa

The goal of this study is to develop and evaluate a social media behavioral intervention based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) to improve transition care for adolescents living with HIV in South Africa. Participants will be randomized to receive the social media intervention or the standard of care.


A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

Study Type: Interventional
Start Date: April 15, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): GPRT / SEARCH Office, Kisumu, Kenya; IDRC Southwest Uganda, Mbarara, Uganda

The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.


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.


Neuroinflammation and Modulating Factors in Depression and HIV

Study Type: Interventional
Start Date: February 1, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Infectious Diseases Institute, Kampala, Uganda

Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.


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.


Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): CRT - Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil; SAE - Serviço de Assistência Especializada Campos Elíseos, São Paulo, Brazil

This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil. The intervention will be evaluated using a randomized wait-list controlled trial to compare uptake of HIV testing (self-testing and clinic-based) (Aim 1), PrEP initiation and persistence (Aim 2), and other prevention services (e.g. harm reduction) among trans women in the intervention arm compared to those in the control arm with data collection scheduled every three-months. Investigators will assess changes in intersectional stigma (Aim 3), including reductions in internalized stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake.


Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya

Study Type: Interventional
Start Date: November 26, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Moi University/ Moi Teaching and Referral Hospital, Eldoret, Kenya

The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of community-based HIV and NCD care with group microfinance will improve retention in care and rates of viral suppression (VS) among people living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and easier access to care.

The specific aims are as follows:

To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) standard care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving standard care and not involved in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is that A > B > C in terms of viral suppression and retention in care. To identify specific mechanisms through which microfinance and integrated community-based care impact VS. Using a mixed methods approach, the study will characterize the mechanisms of effect on patient outcomes. Investigators will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). Investigators will also use qualitative methods and multi-stakeholder panels to contextualize implementation of the intervention. To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. The working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved.

The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.


Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Study Type: Interventional
Start Date: November 26, 2020
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Kenya Medical Research Institute, Kisumu, Kenya; Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project), Thika, Kenya

A pilot study to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.


Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Study Type: Interventional
Start Date: October 5, 2020
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Akala Subcounty Hospital, Siaya, Kenya; Ukwala Subcounty Hospital, Ukwala, Siaya, Kenya; Sigomere Health Center, Sigomere, Siaya, Kenya; Malanga Subcounty Hospital, Malanga, Siaya, Kenya; Bondo Subcounty Hospital, Bondo, Siaya, Kenya; Ambira Subcounty Hospital, Ambira, Siaya, Kenya; Likoni Subcounty Hospital, Likoni, Mombasa, Kenya; Vipingo Subcounty Hospital, Vipingo, Kilifi, Kenya; Mtwapa Subcounty Hospital, Mtwapa, Kilifi, Kenya; Mariakani Subcounty Hospital, Mariakani, Kilifi, Kenya; Siaya County Hospital, Siaya, Kenya; Yala Subcounty Hospital, Yala, Siaya, Kenya

The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.


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.


iTransition Development

Study Type: Interventional
Start Date: August 28, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States; University of Pennsylvania Health System - HUP and Presby infectious disease clinics, Philadelphia, Pennsylvania, United States; Grady Hospital, Atlanta, Georgia, United States

Youth living with HIV are at high risk of falling out of care when they transition from pediatric to adult care. The investigators are proposing to develop a mobile app to help both clinical providers and patients navigate this process.


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.


Streamlining the Efficiency of PrEP Implementation

Study Type: Observational
Start Date: May 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Partners in Health Research and Development, Thika, Kenya

This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.


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.


Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)

Study Type: Interventional
Start Date: January 21, 2020
Eligibility: Males, 18 Years to 29 Years, Accepts Healthy Volunteers
Location(s): Lurie Children's Hospital, Chicago, Illinois, United States; Columbia University School of Nursing, New York, New York, United States

The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.


A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)

Study Type: Interventional
Start Date: October 9, 2019
Eligibility: Males, 18 Years to 34 Years, Accepts Healthy Volunteers
Location(s): Northwestern University, Chicago, Illinois, United States

This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.


Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

Study Type: Interventional
Start Date: August 14, 2019
Eligibility: 18 Years to 89 Years, Does Not Accept Healthy Volunteers
Location(s): University of Alabama, Birmingham, Alabama, United States

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.


Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

Study Type: Interventional
Start Date: July 12, 2019
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Marondera Provincial Hospital, Marondera, Mashonaland East, Zimbabwe

A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.


The PrEP (Pre-exposure Prophylaxis) SMART Study

Study Type: Interventional
Start Date: May 16, 2019
Eligibility: Females, 18 Years to 25 Years, Accepts Healthy Volunteers
Location(s): Wits Reproductive Health and HIV Institute, Johannesburg, South Africa

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.


Pre-exposure Prophylaxis (PrEP) at Home

Study Type: Interventional
Start Date: April 26, 2019
Eligibility: Males, 18 Years to 49 Years, Accepts Healthy Volunteers
Location(s): Emory University, PRISM Health, Atlanta, Georgia, United States; MetroHealth, Cleveland, Ohio, United States; Washington University AIDS Clinical Trial Unit, Saint Louis, Missouri, United States; Open Arms Health Care Center, Jackson, Mississippi, United States; The Fenway Institute, Boston, Massachusetts, United States

This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.


eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men

Study Type: Interventional
Start Date: January 23, 2019
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Brown University School of Public Health, Providence, Rhode Island, United States

The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.


Optimizing mHealth for Adherence Monitoring and Intervention

Study Type: Interventional
Start Date: March 28, 2018
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Kabwohe Clinical Research Center, Kabwohe, Sheema District, Uganda

High and sustained adherence is critical for achieving the individual and public health benefits of HIV antiretroviral therapy (ART). Electronic adherence monitors provide a detailed understanding of adherence and enable real-time interventions. Research has shown the benefit of these monitors and low-cost models have recently become available; however, their use to date has largely been confined to the research context.

This study is an implementation science-driven assessment of strategies to improve uptake of electronic adherence monitoring and associated interventions for routine, clinical delivery of ART in Uganda. The study consists of two aims. In Aim 1, the investigators will conduct multi-level formative interviews to design a preliminary implementation strategy. In Aim 2, the investigators will use an iterative approach to optimize the implementation strategy. All work will be guided by the Consolidated Framework for Research Implementation.


Effects of Glucocorticoids on Cognition in HIV-infected Women

Study Type: Interventional
Start Date: November 20, 2017
Eligibility: Females, 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.


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): 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; Seattle Children's Hospital, Seattle, Washington, United States; SUNY Stony Brook, Stony Brook, New York, United States; Boston Medical Center, Boston, Massachusetts, United States; Johns Hopkins University, Baltimore, Maryland, United States; Rush University Cook County Hospital Chicago, Chicago, Illinois, 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.


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): 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; San Juan Research Hospital, San Juan, Puerto Rico; Baylor College of Medicine, Houston, Texas, United States; 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

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 into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.