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Featured Studies

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

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.

IMPAACT 2015 - Evaluation of the HIV-1 Reservoir in the Central Nervous System of Perinatally-Infected Youth and Young Adults With Cognitive Impairment

Study Type: Observational
Start Date: September 26, 2018
Location: Seattle, Washington
Eligibility: Ages 13–24, Does Not Accept Healthy Volunteers

IMPAACT 2015 is a cross-sectional, exploratory study that will investigate the central nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on effective antiretroviral therapy with neurocognitive impairment. The study will assess the frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population and assess whether detectable HIV in the CSF correlates with markers of inflammation and neuronal injury. Findings from this study will advance understanding of the role of the CNS in HIV-1 persistence and its implications for future HIV-1 remission research.

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study

Study Type: Interventional
Start Date: July 23, 2018
Location: Aurora, Colorado
Eligibility: Ages 15–24, Accepts Healthy Volunteers

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented.

The project has the following important specific aims:

Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure.

Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. The investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board.

Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

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.

Improving Health Outcomes for Women Living With HIV

Study Type: Interventional
Start Date: May 7, 2018
Location: São Paulo, Brazil
Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

This study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women.

Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy

Study Type: Interventional
Start Date: April 24, 2018
Location: Shinyanga, Shinyanga Region, Tanzania
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months

2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Study Type: Interventional
Start Date: April 11, 2018
Location: Kampala, Uganda
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Study Type: Interventional
Start Date: March 23, 2018
Location: Masaka, Uganda
Eligibility: Females, Ages 15–17, Accepts Healthy Volunteers

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

ATN 151 Work-to-Prevent: Employment as HIV Prevention

Study Type: Interventional
Start Date: March 20, 2018
Location: Chicago, Illinois
Eligibility: Males, Ages 16–24, Accepts Healthy Volunteers

The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.

Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

Study Type: Interventional
Start Date: March 1, 2018
Locations: Shinyanga, Shinyanga Region, Tanzania; Shinyanga, Shinyanga, Region, Tanzania; Shinyanga, Tanzania
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.

Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care In Kisarawe, Tanzania

Study Type: Interventional
Start Date: February 5, 2018
Location: Dar Es Salaam, Tanzania
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 89 newly enrolled patients per community.

Specifically, the aims are to determine:

1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing.

2. If integrating DM/HTN care with HIV care enhances engagement in HIV care.

3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care.

4. The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.

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.

Triggered Escalating Real-time Adherence (TERA) Intervention

Study Type: Interventional
Start Date: February 1, 2018
Locations: Birmingham, Alabama; Los Angeles, California; Aurora, Colorado; Jacksonville, Florida; Baltimore, Maryland; Detroit, Michigan; Bronx, New York; Memphis, Tennessee
Eligibility: Ages 13–24, Accepts Healthy Volunteers

Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.

Dyadic-Based Diagnosis, Care and Prevention for HIV Discordant Couples in Tanzania

Study Type: Observational
Start Date: November 21, 2017
Location: Dar Es Salaam, Pwani, Tanzania
Eligibility: Ages 18–55, Accepts Healthy Volunteers

This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. We will identify HIV sero-discordant couples through the HIV self-testing component, and through identifying discordant couples at the local HIV clinic. HIV sero-discordant couples (N=60 couples) will be administered a baseline, 6- ,12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data.

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.

Innovative Approaches for Minor Consent: Consent 2.0

Study Type: Interventional
Start Date: November 7, 2017
Locations: Aurora, Colorado; Tampa, Florida; Chicago, Illinois; Baltimore, Maryland
Eligibility: Ages 14–17, Accepts Healthy Volunteers

The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.

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.

Project WERK (Wellness Encouragement Respect Kinship)

Study Type: Interventional
Start Date: October 9, 2017
Location: Chicago, Illinois
Eligibility: Males, Ages 18–35, Accepts Healthy Volunteers

The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM). The intervention has been developed with input from clients and their support network members, case managers, social workers, primary care providers. The goal of the intervention is to improve retention in PrEP care for young Black MSM.

Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi

Study Type: Interventional
Start Date: September 25, 2017
Location: Lilongwe, Central District, Malawi
Eligibility: Ages 15 and Older, Does Not Accept Healthy Volunteers

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year.

Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

Study Type: Interventional
Start Date: July 1, 2017
Location: Mbarara, Uganda
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

HIV antiretroviral therapy has the potential to dramatically decrease HIV transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is the fact that healthcare is largely provided by traditional or spiritual healers rather than biomedical providers, and there are no strategies in place to identify HIV-infected patients among Traditional Healer patients and link them to HIV care. In order to reach the UNAIDS 90-90-90 benchmarks HIV services must reach marginalized populations in endemic regions, such as in southwestern Uganda. Uganda is one of seven sub-Saharan African (SSA) countries accounting for 90% of all new HIV infections in this region6. HIV prevalence is 7.3%, with ~1.5 million people living with HIV/AIDS and 99,000 new infections in 2014. However, only 50% of sexually active Ugandans have ever tested for HIV8. In the project location of southwestern Uganda, like much of SSA, the majority of Ugandans utilize Traditional Healers (TH), but little is known about Traditional Healer practices or rates of HIV testing (or HIV infection) among their clients. Specific aims of this study are to: 1) identify key socio-structural factors that frame HIV testing behaviors among Ugandan adults who utilize Traditional Healers; 2) investigate acceptability of providing point-of-care HIV testing at Traditional Healer practice locations; and 3) develop and pilot a prospective HIV testing intervention among Traditional Healer patients to promote earlier diagnosis. Results will be used to implement subsequent, large-scale cluster-randomized HIV testing intervention at Traditional Healer practice locations. Findings from the proposed study include formative data on populations that utilize Traditional Healers in an HIV-endemic region of Uganda, and pilot testing of an HIV testing intervention at healer practice locations; these results could be applied towards expanding HIV testing in other low-resource, endemic settings.

Improving South African Government Workers' Capacities to Deliver HIV Interventions

Study Type: Interventional
Start Date: June 1, 2017
Locations: Stellenbosch, South Africa; Zithulele, South Africa
Eligibility: Females, Ages 15–49, Accepts Healthy Volunteers

The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.

Retention in HIV Care for Hispanic Immigrants

Study Type: Interventional
Start Date: May 26, 2017
Location: Boston, Massachusetts
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

A randomized trial to test the feasibility and acceptability of an intervention to improve retention in HIV primary care in HIV-infected Hispanic immigrants compared to a "treatment as usual" condition. We will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. The intervention design is based on qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The intervention will be led by a Spanish-speaking community health worker trained in HIV health promotion.

Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk

Study Type: Interventional
Start Date: May 24, 2017
Location: Kisumu, Kenya
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

Youth mHealth Adherence Intervention for HIV+ YMSM

Study Type: Interventional
Start Date: May 22, 2017
Location: Philadelphia, Pennsylvania
Eligibility: Males, Ages 14–24, Accepts Healthy Volunteers

This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.

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

Study Type: Interventional
Start Date: May 1, 2017
Location: Philadelphia, 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 (n=320) 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.

The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

Study Type: Observational
Start Date: March 13, 2017
Location: Harare, Zimbabwe
Eligibility: Ages 18–35, Accepts Healthy Volunteers

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

The Partners Scale-Up Project

Study Type: Interventional
Start Date: February 6, 2017
Locations: Kisumu, Kenya; Thika, Kenya
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.

Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women

Study Type: Interventional
Start Date: January 31, 2017
Location: New Delhi, India
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

Depression is a common perinatal complication that can have a profound, adverse effect on maternal and child health outcomes. The proposed study will directly address this important, but understudied area by evaluating the feasibility and preliminary effect of an innovative, integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided by a model drawn from self-regulation and bioecological systems theory. Proactive counseling personalized to the patient and socio-cultural context is delivered by trained clinic personnel (e.g., counselors) to build problem solving and coping skills and linkages to mental health, HIV treatment and ancillary services. The theory-guided intervention approach has been found effective in improving the health behavior and outcomes (e.g., virologic) of vulnerable, marginalized HIV+ women and men in rural and urban settings in the US (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that it is well suited for the target population, its usefulness in addressing significant gaps in care among perinatal women.

l women with co-morbid conditions in a different socio-cultural, limited resource setting has not been studied.

Family Planning and HIV in Postpartum Women in Mbarara

Study Type: Interventional
Start Date: December 31, 2016
Location: Mbarara, Uganda
Eligibility: Ages 18–48, Accepts Healthy Volunteers

Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's health through family planning choices, regular health reviews, and support. A cohort study that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women having no desire for a (another) child during the 4 years since ART initiation, 51% had a serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of contraceptive use were family planning goals within the DYAD. One of the key predictors of effective contraceptive use was male partner involvement and CD4 count. The WHO recommends dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at providing information on whether continuous family planning accessibility and support has a measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV positive mothers delivering at MRRH, SW Uganda.

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.

Positive Connections: COPA2

Study Type: Interventional
Start Date: July 31, 2016
Location: Buenos Aires, Argentina
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina

Innovative Behavioral Economics Incentives Strategies for Health

Study Type: Interventional
Start Date: April 30, 2016
Location: Mbarara, Uganda
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

The success of combination HIV prevention efforts, including HIV treatment as prevention, hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The proposed study will evaluate the comparative effectiveness and sustainability of innovative incentive strategies, informed directly by behavioral economics and decision psychology, to promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.

Addressing Psychosocial Comorbidities in HIV Treatment and Prevention

Study Type: Interventional
Start Date: March 31, 2016
Location: Miami, Florida
Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.

Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Study Type: Interventional
Start Date: December 31, 2015
Location: Miami, Florida
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and prescribed traditional gender roles) that have been associated with medication nonadherence or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

Motivational Enhancement System for Adherence (MESA) for Youth Starting ART

Study Type: Interventional
Start Date: August 31, 2015
Locations: Miami, Florida; Detroit, Michigan
Eligibility: Ages 16–24, Does Not Accept Healthy Volunteers

This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, and Washington, DC), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the intervention, Motivational Enhancement System for Adherence (MESA), or the control condition, System for Health (SH: healthy eating and physical activity information). Both groups receive the standard of care regarding the initiation of ART. ART adherence (visual analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and predictors of intervention response (substance abuse, mental health symptoms, executive functioning, and stressful life events) are assessed.

Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique

Study Type: Interventional
Start Date: June 10, 2015
Location: Namacurra, Zambezia, Mozambique
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.

Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection

Study Type: Interventional
Start Date: August 31, 2014
Location: Bangkok, Thailand
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This research project will study whether the drug telmisartan administered in conjunction with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The investigators are studying the effect of this treatment in people who have contracted HIV infection within the past three weeks, and thus have a form of HIV called acute HIV infection. The investigators will measure biological markers of immune activation in the blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs in affected patients.

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.

Safer Sex Program for Young African-American Men

Study Type: Interventional
Start Date: September 30, 2012
Location: Jackson, Mississippi
Eligibility: Males, Ages 15–29, Accepts Healthy Volunteers

To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses:

Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing.

H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition.

H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition.

H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition.

H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition.

H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.