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Featured Studies

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

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

Study Type: Interventional
Start Date: November 12, 2021
Location: Johannesburg, Gauteng, South Africa
Eligibility: Females, Ages 18 and Older, Accepts Healthy Volunteers

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
Location: Sweetwaters, Kwa-zulu Natal, South Africa
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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.

Interrupting HIV and TB Stigma in the Household in Uganda

Study Type: Interventional
Start Date: October 25, 2021
Location: Kampala, $location.state, Uganda
Eligibility: Ages 15 and Older, Accepts Healthy Volunteers

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.

INcentives and ReMINDers to Improve Long-term Medication Adherence

Study Type: Interventional
Start Date: October 25, 2021
Location: Kampala, $location.state, Uganda
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.

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

Study Type: Interventional
Start Date: September 14, 2021
Location: San Diego, California
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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.

Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India

Study Type: Interventional
Start Date: August 13, 2021
Location: Bangalore, Karnataka, India
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess pill ingestion, and size/expense. Our multidisciplinary research team at the University of California, San Francisco (UCSF) and in India has designed a new adherence-monitoring device called "Tel-Me-Box" which is small, low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time adherence reminders following additional hardware modifications. The aim of this study is to modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a measure pioneered and validated by our team, with the expectation that this device and intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence science, both in India and globally.

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

Study Type: Interventional
Start Date: August 1, 2021
Location: Guangzhou, Guangdong, China
Eligibility: Males, Ages 18–99, Does Not Accept Healthy Volunteers

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
Locations: Jacksonville, Florida; Chicago, Illinois; Johannesburg, Gauteng, South Africa
Eligibility: Females, Ages N/A and Older, Does Not Accept Healthy Volunteers

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
Location: Siaya, $location.state, Kenya
Eligibility: Females, Ages N/A and Older, Accepts Healthy Volunteers

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
Location: Westville, $location.state, South Africa
Eligibility: Ages 15–19, Does Not Accept Healthy Volunteers

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
Location: Mbarara, $location.state, Uganda
Eligibility: Ages 15 and Older, Accepts Healthy Volunteers

The overall objective is to determine to reduce HIV incidence and to improve community health with multi-sector, scalable interventions. This study will consist of two phases: Phase A, in which randomized trials will assess effectiveness, fidelity and cost and improve context-specific "fit" of prevention and treatment interventions. Combining effectiveness with implementation, costing and modelling outcomes, Phase A will optimize intervention packages with context specific adaptations in structured consultation with stakeholders. Phase B, which will evaluate the effects of these optimized dynamic prevention and treatment packages, alone and in combination, on prevention coverage, population-level suppression, and HIV incidence, as well as other health outcomes, in a balanced, community randomized 2x2 factorial design. This clinicaltrial.gov registration is for Phase A.

Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa

Study Type: Interventional
Start Date: April 12, 2021
Location: Cape Town, $location.state, South Africa
Eligibility: Females, Ages 18 and Older, Accepts Healthy Volunteers

Despite high levels of adherence motivation during pregnancy, HIV treatment adherence and engagement in care is difficult for women in the postpartum period. Supporting women during the transition from pregnancy to postpartum is imperative to sustaining HIV treatment adherence during this period. The investigators are conducting a small scale pilot study of a behavioral Transition Theory-based intervention to support ART adherence and engagement in ART services among pregnant and postpartum women living with 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
Location: Kisumu, $location.state, Kenya
Eligibility: Females, Ages N/A and Older, Accepts Healthy Volunteers

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
Location: Cape Town, $location.state, South Africa
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

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. The investigators propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after antiretroviral therapy (ART) initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are newly 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
Location: Kampala, $location.state, Uganda
Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

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.

PositiveLinks: mHealth for DC Cohort

Study Type: Interventional
Start Date: January 5, 2021
Location: Washington, District of Columbia
Eligibility: Ages 16 and Older, Does Not Accept Healthy Volunteers

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 13 DC Cohort sites among 560 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.

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Study Type: Interventional
Start Date: December 21, 2020
Location: Providence, Rhode Island
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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
Location: São Paulo, $location.state, Brazil
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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
Location: Eldoret, $location.state, Kenya
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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
Locations: Kisumu, $location.state, Kenya; Thika, $location.state, Kenya
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

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

The Shauriana Intervention for GBMSM in Kenya

Study Type: Interventional
Start Date: October 28, 2020
Location: Kisumu, $location.state, Kenya
Eligibility: Males, Ages 18–35, Accepts Healthy Volunteers

The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Study Type: Interventional
Start Date: October 5, 2020
Locations: Mariakani, Kilifi, Kenya; Mtwapa, Kilifi, Kenya; Vipingo, Kilifi, Kenya; Likoni, Mombasa, Kenya; Ambira, Siaya, Kenya; Bondo, Siaya, Kenya; Malanga, Siaya, Kenya; Sigomere, Siaya, Kenya; Ukwala, Siaya, Kenya; Yala, Siaya, Kenya; Siaya, $location.state, Kenya
Eligibility: Females, Ages N/A and Older, Does Not Accept Healthy Volunteers

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
Locations: Miami, Florida; Boston, Massachusetts
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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
Locations: Storrs, Connecticut; Atlanta, Georgia
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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
Location: Philadelphia, Pennsylvania
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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.

AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial

Study Type: Interventional
Start Date: July 8, 2020
Location: Chapel Hill, North Carolina
Eligibility: Males, Ages 15–24, Does Not Accept Healthy Volunteers

AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.

Streamlining the Efficiency of PrEP Implementation

Study Type: Observational
Start Date: May 1, 2020
Location: Thika, $location.state, Kenya
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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
Location: Chicago, Illinois
Eligibility: Males, Ages 18–34, Does Not Accept Healthy Volunteers

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.

COMMIT HIV Trial Nepal

Study Type: Interventional
Start Date: February 25, 2020
Location: Sanfebagar-10, Achham/Province 7, Nepal
Eligibility: Ages 15 and Older, Does Not Accept Healthy Volunteers

Community Healthcare Workers (CHWs), who live in the communities they serve, have the potential to reach patients who poorly engage in their care. Motivational Interviewing (MI) is a special type of interactional approach that focuses on improving the person's motivation to engage in healthy behaviors, such as keeping their clinic appointments and regularly taking medications. In this study, we will develop a mobile health tool that will assist CHWs in two tasks while they utilize MI to assist patients' engagement in care: 1) follow prompts on the mobile device to deliver MI; and 2) record consented conversations between CHWs and patients so that MI specialists can review the audiotape and provide feedback to maintain the MI skills.

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

Study Type: Interventional
Start Date: January 21, 2020
Location: New York, New York
Eligibility: Males, Ages 18–29, Accepts Healthy Volunteers

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.

Comparison of Men's Prevention Apps to Research Efficacy

Study Type: Interventional
Start Date: October 14, 2019
Locations: Philadelphia, Pennsylvania; Houston, Texas
Eligibility: Males, Ages 15–24, Accepts Healthy Volunteers

A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).

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
Location: Chicago, Illinois
Eligibility: Males, Ages 18–34, Accepts Healthy Volunteers

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.

Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US

Study Type: Observational
Start Date: October 7, 2019
Location: Atlanta, Georgia
Eligibility: Females, Ages 13–45, Accepts Healthy Volunteers

Pre-exposure Prophylaxis (PrEP) is a daily pill to prevent HIV that, when taken as prescribed, reduces the risk of getting HIV from sexual intercourse or drug use. In the United States, most studies which examine prescribing PrEP have not included young women. PrEP provides a way for women to take control of their HIV prevention and may be a good option for some women.

Family planning clinics are a trusted source of preventative, routine, and symptom-driven gynecological care for adolescent and young adult women (AYAW). Thus, these clinics are a natural setting to provide PrEP services for AYAW. This study will examine how effectively three clinics in Atlanta are able to implement a PrEP program for their eligible female patients as well as follow a cohort of 300 women for six months (150 starting PrEP immediately and 150 electing to not take PrEP, at least initially) to characterize individual, provider, and clinic-level variables and constructs that are associated with PrEP uptake, continuation, and adherence.

Both participant and biological data will be collected to answer the primary research question. Women will provide blood, urine, oral, vaginal, anal, and hair samples at three different time points. These samples will be tested to measure incident sexually transmitted infections and unplanned pregnancies as well as PrEP adherence (for women who initiated PrEP). Ultimately, this data will describe each clinic's effectiveness at providing PrEP services to AYAW.

Personalized HIV and STI Testing Tool

Study Type: Interventional
Start Date: September 18, 2019
Location: San Francisco, California
Eligibility: Males, Ages 18–29, Accepts Healthy Volunteers

The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.

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
Location: Birmingham, Alabama
Eligibility: Ages 18–89, Does Not Accept Healthy Volunteers

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
Location: Marondera, Mashonaland East, Zimbabwe
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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
Location: Johannesburg, $location.state, South Africa
Eligibility: Females, Ages 18–25, Accepts Healthy Volunteers

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.

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Study Type: Interventional
Start Date: May 7, 2019
Location: Chapel Hill, North Carolina
Eligibility: Males, Ages 16–29, Does Not Accept Healthy Volunteers

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

Pre-exposure Prophylaxis (PrEP) at Home

Study Type: Interventional
Start Date: April 26, 2019
Location: Cleveland, Ohio
Eligibility: Males, Ages 18–49, Accepts Healthy Volunteers

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.

Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania

Study Type: Interventional
Start Date: March 5, 2019
Location: Mwanza, $location.state, Tanzania
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.

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
Location: Providence, Rhode Island
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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.

VITAL Start: Brief Facility-based Video Intervention

Study Type: Interventional
Start Date: October 1, 2018
Location: Lilongwe, $location.state, Malawi
Eligibility: Females, Ages 16 and Older, Accepts Healthy Volunteers

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care

Study Type: Interventional
Start Date: May 25, 2018
Location: San Francisco, California
Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

The proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).

Optimizing mHealth for Adherence Monitoring and Intervention

Study Type: Interventional
Start Date: March 28, 2018
Location: Kabwohe, Sheema District, Uganda
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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.

Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission

Study Type: Interventional
Start Date: February 1, 2018
Location: Chimoio, Manica, Mozambique
Eligibility: Ages 15 and Older, Accepts Healthy Volunteers

Optimizing the prevention of mother-to-child HIV transmission cascade minimizes drop offs from one step to the next to maximize the benefits of antiretroviral therapy on maternal health and pediatric survival, growth, and development. This proposal scales-up a health systems intervention (the systems analysis and improvement approach - SAIA) that packages systems engineering methods (including cascade analysis, flow mapping, and continuous quality improvement) and was previously shown to be effective in improving the prevention of mother-to-child HIV transmission cascade. By spreading the SAIA through routine district management structures, and studying the implementation process, this study will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource limited countries.

Effects of Glucocorticoids on Cognition in HIV-infected Women

Study Type: Interventional
Start Date: November 20, 2017
Location: Baltimore, Maryland
Eligibility: Females, Ages 18–65, Does Not Accept Healthy Volunteers

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
Locations: Los Angeles, California; Atlanta, Georgia; Chicago, Illinois; Baltimore, Maryland; Boston, Massachusetts; Stony Brook, New York; Seattle, Washington
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

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.

Impact of Representative Payee Services on ART Adherence Among Marginalized People Living With HIV/AIDS

Study Type: Interventional
Start Date: May 1, 2017
Locations: Birmingham, Alabama; Pittsburgh, Pennsylvania
Eligibility: Ages 18–100, Does Not Accept Healthy Volunteers

Client-Centered Representative Payee is a structural intervention that provides financial management support to PLWHA by modifying the implementation of a long-standing policy within the Social Security Administration, in which an organization is authorized to serve as the client's payee. The central hypothesis of this study is that by helping clients to pay rent and other bills on time, housing stability will improve and financial stress will decrease. By reducing the cognitive burden of living with chronic financial stress and frequent threats of housing loss, clients can devote more time and attention to medical appointments and medication adherence. It is further hypothesized that these changes will improve clients' self-efficacy for health behaviors, retention in care, medication adherence, and viral loads. These hypotheses will be tested via the following specific aims: (1) Conduct a randomized controlled trial with two randomized arms (n=160) and two non-randomized arms (n=50) to test the effect of Client-Centered Rep Payee on ART adherence and viral load among PLWHA who are economically disadvantaged and unstably housed. Clinical adherence will be compared through behavioral and biological measures including prescription refill data, self-reported appointment adherence, and viral load for patients receiving the intervention versus those receiving standard of care. (2) Test underlying mechanisms associated with Client-Centered Rep Payee that contribute to changes in medication adherence and viral suppression rates. This will be accomplished via use of quantitative (mediation analysis) and qualitative (semi-structured interview) methods to test hypothesized mediators of medication adherence and viral suppression including financial and housing instability, financial stress, self-efficacy for health behaviors, and retention in care. (3) Assess the cost and cost-effectiveness of the Client-Centered Rep Payee model. An economic analysis will be conducted to model the impact of the intervention as compared with standard of care on quality adjusted life years as well as new infections averted. This approach is innovative because it offers a structural intervention to improve adherence by addressing the effects of economic insecurity, requires low financial investment, and can be layered with existing clinical services. Further, it is highly scalable as it builds on a current policy in practice within the Social Security system.

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

Study Type: Observational
Start Date: April 30, 2014
Location: San Juan, $location.state, Puerto Rico
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

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.