Clinical Research Directory

Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda

The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.

Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator

The goal of this study is to learn whether adults who visit a hospital emergency department (ED) find it acceptable to start HIV pre-exposure prophylaxis (PrEP) during that same visit, with help from a peer navigator. PrEP is a daily pill that lowers the chance of getting HIV. Many people who could benefit from PrEP use the ED for health care but have no regular doctor, so they may never be offered it. The main questions this study aims to answer are: * Do participants find starting PrEP in the ED acceptable? * How many participants take the first dose, connect with an ongoing PrEP provider, and keep taking PrEP over one year? At Tampa General Hospital, a peer PrEP navigator (a trained study team member) will offer PrEP information to adults in the ED. Adults who agree to join the study and test HIV-negative will: * take their first PrEP pill in the ED while the navigator watches, and leave with a 29-day supply at no cost * choose a community PrEP provider for ongoing care, with help from the navigator * answer short surveys before leaving the ED and by phone at 2-3 days, 30 days, 60 days, 90 days, and 1 year * allow the navigator to confirm follow-up PrEP lab work with their outside provider at about 120 days

mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System

This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools. The study will: * Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services. * Refine and test the updated program to make sure it works well and is easy to use. * Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services. The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.

Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

Examining Migration, Social Bonds, Transnationalism, and HIV Prevention Pathways Among African Immigrants.

The goal of this mixed-methods pilot study is to learn whether migration experiences, social bonds, and transnational ties shape HIV prevention decision-making, including HIV testing, HIV self-testing (HIVST), and pre-exposure prophylaxis (PrEP) uptake, among first-generation African immigrants aged 18 to 50 residing in New York and Massachusetts. The main questions it aims to answer are: * What relationship typologies and migration-related relational mechanisms influence HIV testing, HIVST, and PrEP decision-making among African immigrants? * Can a relationship-tailored HIV prevention intervention component, co-developed with the community, demonstrate feasibility and acceptability among African immigrants? * Does exposure to the prioritized intervention component show directional increases in HIV testing intention, willingness to use HIVST, interest in PrEP, and readiness for relationship-based prevention communication? There is no comparison group. All Aim 3 participants receive the same co-developed intervention component. Participants will: * Complete a qualitative interview (60-90 minutes) and/or a structured electronic survey (15-20 minutes) about their relationship experiences, migration history, and HIV prevention behaviors. * Take part in a 3-4 hour structured group deliberation session called a Palava Hut Conversation to co-develop and prioritize HIV prevention intervention ideas. * Complete a baseline survey, receive the prioritized intervention component in a structured Zoom session, and complete a follow-up survey with an optional 60-90 minute cognitive interview for a subset of participants.

Intervention to Enhance PrEP Persistence

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

Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment

Many people who are experiencing homelessness are at high risk for HIV, but they often have trouble getting HIV prevention or treatment. Testing may be offered where they are, but starting medication usually requires going to a clinic somewhere else, and many people are not able to make that second trip. This study tests a program called CONNECT. In CONNECT, a community health worker and a nurse offer HIV services directly at homeless shelters. People can take an HIV self-test on-site. If the test is negative and the person is at risk for HIV, the nurse can start them the same day on a prevention medicine called PrEP. If the test is positive, the nurse can help them start HIV treatment quickly and connect to ongoing care. The study will compare this on-site program to the usual approach of referring people elsewhere, to see whether it helps more people start HIV prevention or treatment on time.

Combatting HIV Or Other STIs Early (CHOOSE)

The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.

Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi

The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is: Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care? Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.

Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.

Leveraging Chatbot to Improve PrEP in the Southern United States

The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.

Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi

Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to: 1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing. 2. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing. 3. Compare implementation outcomes between the PAC-Man model and SOC. Participants: The total study sample size is 2,426, including 2,304 mother-infant pair (MIP) survey participants, 48 high-risk pregnant/breastfeeding women living with HIV for in-depth interviews (from high-risk MIPs who participated in a survey); 10 PMTCT policy makers and Ministry of Health (MOH)/ President's Emergency Plan for AIDS Relief (PEPFAR) implementing partner senior managers for key informant interviews; and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys. To rigorously evaluate the PAC-Man model, investigators will use a hybrid (type 3) effectiveness-implementation incomplete stepped-wedge trial design. The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental "rollout" of the PAC-Man model and serial measurement of both health outcomes (for infants and mothers in Objectives 1 and 2, respectively), as well as implementation outcomes (Objective 3). The incomplete stepped-wedge design is more efficient than a complete design, minimizes costs, and reduces participant burden, without sacrificing statistical precision. Using this design, sequential crossover from control (i.e., the SOC) to intervention (i.e., SOC plus the PAC-Man model) takes place at each 'step' using cluster randomization until all clusters (defined as a group of "sites," or health facilities plus the surrounding communities in its catchment area) receive the intervention. The 12 sites included in our study will be divided into 4 clusters of 3 sites each.

Pharmacies in HIV Prevention: Fellowship, Fundamentals, and Sustainable Finances

Quantify the impact of an online Virtual Community of Practice (VCoP) to increase pharmacist knowledge and accelerate provision of pre-exposure prophylaxis (PrEP) for HIV prevention.

Private-sector Access to Testing for Health Sustainability

New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. To ensure the real-world sustainability of free distribution of HIV self-test kits to AGYW by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of HIV-self test kits to AGYW combined with prosocial motivational supports. The combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for AGYW at scale.

Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.

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

Social Media as a Risk Tool for HIV Prevention Needs

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

Using PrEP, Doing It for Ourselves

The goal of this clinical trial is to test a new online program called UPDOs Protective Styles to help people in the southeastern United States learn about and start using PrEP (pre-exposure prophylaxis), a medicine that helps prevent HIV. The study focuses on people who may be at higher risk for HIV and have not had equal access to PrEP. The main questions it aims to answer are: Does UPDOs help more people trust and understand PrEP? Does UPDOs increase the number of people who start and continue using PrEP? Researchers will compare two groups: One group will use UPDOs, which includes six weekly videos, blog discussions, and access to telehealth services through Q Care Plus. The other group will receive standard HIV prevention materials from the CDC. Participants will: Be recruited from 32 beauty salons in areas with high HIV rates. Complete surveys at the start of the study and again at 6, 12, 24, 32, and 52 weeks. Have access to HIV testing and PrEP prescriptions through Q Care Plus. This study will also look at how well the program works in different communities and how easy it is to use and share.

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)

Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 \& 3 participants will also complete brief phone surveys (\<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.

Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi

Purpose: To evaluate short-term efficacy and implementation of Treat4All, an alcohol reduction evidence-based intervention, for decreasing heavy drinking and optimizing HIV outcomes (viral suppression among People with HIV (PWH); Pre-exposure prophylaxis (PrEP) use among those at high risk of HIV) Participants: Approximately 160 participants aged 18 years or older will be enrolled into this study. Eligible participants will be recruited from two groups of individuals: Persons at risk of HIV: Individuals receiving (STI) care who report recent heavy drinking (n=80) and no recent use of PrEP. Persons with HIV: Individuals with HIV who report recent heavy drinking and either a history of unsuppressed viral load or recent suboptimal adherence to ART (n=80). Procedures (methods): Pilot two-arm randomized controlled trial (1:1; Treat4All Intervention vs Usual Care)

PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men

This type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP \& Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment attendance among men. Using mixed methods and implementation science approaches, this parallel cluster randomized controlled study will assess key implementation factors at CVS Health pharmacy locations assigned either to the PrEP \& Soccer intervention or to a general CVS Health service information-only control.

Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program

Though broadening PrEP (Pre-Exposure Prophylaxis) availability to Louisiana pharmacies addresses key access issues for Louisiana's population, there is no current baseline data which explore current pharmacist and pharmacies' capacity to effectively provide PrEP therapy to patients who meet PrEP prescribing criteria. This study aims to explore1) Louisiana pharmacist and pharmacy capacity to provide PrEP under a state-based collaborative practice agreement, 2) a validated pharmacist education system addressing health disparities in PrEP prescribing and 3) the impact of state pharmacy based policies on equitable PrEP prescribing. Our central hypothesis is pharmacist trained in PrEP prescribing focusing on health disparities and implicit bias education and working with mentors in an implementation framework will have an increase in equitable PrEP prescribing

Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico

To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino eligible men in Puerto Rico.

PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI)

The goal of this clinical trial is to learn if use of the PEPPI software can improve pharmacist-provided HIV prevention (PEP/PrEP) services. The main questions it aims to answer are: 1. Does the PEPPI software make it easier for pharmacists to provide PEP/PrEP services in their pharmacy? 2. Does the PEPPI software make it easier for patients to access PEP/PrEP? Researchers will compare pharmacists' implementation and patients' access when using the PEPPI software and when not using the PEPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide PEP/PrEP services as normal while using the PEPPI software. Patients will be asked to receive PEP/PrEP services from a pharmacist as normal, while using the PEPPI software.

Safe Spaces 4 Sexual Health

In an earlier study, the study team carried out an HIV/Sexually transmitted infection (STI) testing approach which found men who have sex with men (MSM) at-risk of getting or spreading HIV in online spaces and linked them to testing services on a mobile van. The goal of this present study is to add on to this approach by connecting participants (MSM aged 18-49 residing in the Baltimore area) with a peer health navigator to support them with getting pre-exposure prophylaxis (PrEP) or HIV care services after testing. Researchers will compare using a peer health navigator approach to using a referrals-only approach to get PrEP or HIV care services. Participants will be assigned to either Arm A (group that receives peer health navigator help) or Arm B (group that gets referred) to get PrEP or HIV care.