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Featured Studies

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

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, 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.

Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

Study Type: Interventional
Start Date: November 26, 2020
Location: Masaka, Uganda
Eligibility: Ages 10–14, Does Not Accept Healthy Volunteers

The study seeks to reduce HIV/AIDS-associated stigma and its negative impact on adolescent health and psychosocial well-being. This study will examine two evidence-informed interventions: 1) group cognitive behavior therapy (G-CBT) that aims at cognitive restructuring and strengthening coping skills at the individual level, and 2) multiple family group (MFG) that strengthens family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. Adolescents between 10-14 years, will be randomly assigned -at the clinic level, to one of three study arms: 1) Usual care to receive the currently implemented usual care addressing HIV/AIDS-associated stigma (educational materials from the Ugandan Ministry of Health); 2) G-CBT intervention + Usual care; and 3) MFG intervention + Usual care. The interventions will be delivered over a 3-month period. Assessments will be collected at baseline, 3 months and 6 months post intervention initiation. The study will also explore participants, caregivers and facilitators' intervention experiences, as well as multi-level facilitators and barriers to intervention implementation and participation.

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

Study Type: Interventional
Start Date: November 26, 2020
Location: Eldoret, 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:

1. 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.

2. 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.

3. 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, Kenya; Thika, 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, 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, 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.

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Study Type: Interventional
Start Date: September 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.

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
Locations: Atlanta, Georgia; 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.

The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

Study Type: Interventional
Start Date: July 20, 2020
Locations: Los Angeles, California; Aurora, Colorado; Miami, Florida; Chicago, Illinois; Memphis, Tennessee; Gaborone, Botswana; Johannesburg, Gauteng, South Africa; Tygerberg, Western Cape Province, South Africa; Bangkok, Bangkoknoi, Thailand; Changklan, Muang, Chiang Mai, Thailand; Chiang Mai, Thailand
Eligibility: Ages 6 Months–12, Does Not Accept Healthy Volunteers

The purpose of this study is to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age.

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, 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
Locations: Chicago, Illinois; 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.

Project Jumpstart for Improving PrEP Care of Continuum Outcomes

Study Type: Interventional
Start Date: January 1, 2020
Location: Atlanta, Georgia
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV.

Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe

Study Type: Interventional
Start Date: December 10, 2019
Location: Lilongwe, Malawi
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce mother-to-child HIV transmission. However, loss to HIV care after delivery has emerged as an important threat to the hoped-for impact of Option B+. Evidence suggests that one important contributor to postpartum loss to HIV care is perinatal depression (PND). In non-pregnant HIV-infected populations, depression has been linked to poor ART adherence, reduced engagement in care, and ultimately worse HIV clinical outcomes. Thus, interventions that integrate PND treatment with targeted support for HIV care retention are critical to the success of Option B+.

The Friendship Bench is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings, but has not been adapted to address PND, or enhanced to support engagement in HIV care. The Friendship Bench offers an ideal framework for integrating retention support into a proven depression treatment model. Our long-term goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve engagement in HIV care. The objective of this proposal is to lay the groundwork for an effectiveness trial by adapting the Friendship Bench intervention to address PND and support engagement in care among perinatal HIV-infected women and assessing the feasibility, acceptability, and fidelity of the adapted intervention in Lilongwe, Malawi. In-depth perspectives on PND and its role in engagement in care will be gathered from HIV-infected women with PND, healthcare providers, clinic directors, and Ministry of Health officials using qualitative interviews and focus groups. This formative research will be used to develop an intervention protocol adapted to the unique needs of HIV-infected women during the perinatal period (Adapted Friendship Bench) and further enhanced to support engagement in HIV care (Enhanced Friendship Bench). The Adapted and Enhanced Friendship Bench interventions will be compared to enhanced standard care in a 3-arm pilot study. Feasibility, acceptability, and fidelity will be assessed at 6 months postpartum, along with the interventions' preliminary effectiveness across several mental health and engagement in HIV care measures.

Comparison of Men's Prevention Apps to Research Efficacy

Study Type: Interventional
Start Date: October 14, 2019
Locations: Bronx, New York; 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 18–29, 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.

Like Father Like Son

Study Type: Interventional
Start Date: October 8, 2019
Location: Lusaka, Zambia
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear & Shield program.

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, 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.

PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico

Study Type: Interventional
Start Date: May 15, 2019
Location: Mexico City, DF, Mexico
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.

DHFS for Medication Adherence Support During Hospital Admissions for Person Living With HIV

Study Type: Interventional
Start Date: May 15, 2019
Location: San Diego, California
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.

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
Locations: Atlanta, Georgia; Boston, Massachusetts; Jackson, Mississippi; Saint Louis, Missouri
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, 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, 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.

Kenya HIV Self-Testing in PrEP Delivery

Study Type: Interventional
Start Date: May 28, 2018
Location: Thika, Kenya
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.

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.

Partners-based HIV Treatment for Couples Attending Antenatal Care

Study Type: Interventional
Start Date: November 20, 2017
Location: Pebane, Zambezia, Mozambique
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couples-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. This innovative approach to scaling up EMTCT services, if proven feasible and effective, will be adopted in President's Emergency Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping families with HIV infection live long, healthy lives.

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.

Stigma and Online Counseling to Increase HIV/STI Testing

Study Type: Interventional
Start Date: December 31, 2016
Location: Atlanta, Georgia
Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.

Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

Study Type: Interventional
Start Date: December 1, 2016
Location: San Diego, California
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication.

The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy

Study Type: Interventional
Start Date: June 30, 2016
Location: San Diego, California
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their ARV medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their ARV medications.

The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to the HIV patient population; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

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

Study Type: Observational
Start Date: April 30, 2014
Locations: La Jolla, California; Aurora, Colorado; Fort Lauderdale, Florida; Miami, Florida; Chicago, Illinois; New Orleans, Louisiana; Boston, Massachusetts; Newark, New Jersey; Bronx, New York; Philadelphia, Pennsylvania; Memphis, Tennessee; Houston, Texas; San Juan, 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.