Clinical trials: HIV/AIDS Prevention
HIV/AIDS
PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and…
- Trial name
- NCT04408729
- Testing
- PrEP My Way
- Where
- Kenya
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Osteoporosis, HIV
Bone Health in Aging HIV Infected Women
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1.
- Conditions
- Osteoporosis, HIV, Menopause
- Trial name
- BEING (NCT02815566)
- Testing
- tenofovir-alafenamide-emtricitabine, tenofovir-emtricitabine
- Where
- 7 sites in Canada, Italy
- Volunteers
- 34 people
- Sponsor
- University Health Network, Toronto
HIV
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
- Trial name
- NCT02732730
- Testing
- Truvada, Drug level counseling at Weeks 8 and 13
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Hiv
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
While HIV prevalence among Men Seeking Men (MSM) in India is 10-15 times higher than in the general population (4.3% vs 0.3%), current interventions for Indian MSM have limited reach.
- Trial name
- NCT04814654
- Testing
- CHALO! 2.0, Attention-matched control (AMC), Digital coupon only (DCO)
- Where
- India
- Volunteers
- 1,004 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV, Pregnancy
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts…
- Trial name
- NCT04571684
- Testing
- HITSystem 2.1
- Where
- 12 sites in Kenya
- Volunteers
- 1,639 people
- Sponsor
- University of Kansas Medical Center
Sexually Transmitted Infections
HIV/STI Prevention for Drug-Involved Couples
This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved.
- Trial name
- ConnectII (NCT01285349)
- Testing
- Couple HIV/STI prevention intervention, Couple-based HIV/STI prevention, Individual HIV/STI prevention
- Where
- United States
- Volunteers
- 564 people
- Sponsor
- Columbia University
Risk Behavior, HIV/AIDS
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and…
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Trial name
- CHRP-BB (NCT03282890)
- Testing
- CHRP-BB
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- University of Connecticut
HIV Infections
A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
This study will pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to antenatal care in Tanzania and male partners who accompany them.
- Trial name
- Maisha (NCT03600142)
- Testing
- Mashia
- Where
- Tanzania
- Volunteers
- 1,539 people, healthy volunteers welcome
- Sponsor
- University of Utah
HIV Infections
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women.
- Trial name
- NCT02985996
- Testing
- Truvada, Genvoya
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Emory University
HIV, Gonorrhea
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections.
- Conditions
- HIV, Gonorrhea, Chlamydia
- Trial name
- KIU! (NCT01836445)
- Testing
- Keep It Up!, HIV Knowledge Control
- Where
- 3 sites in United States
- Volunteers
- 901 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Mobile Phone Use, Hiv
Mobile HIV Prevention App for Black Women
Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts. The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically…
- Conditions
- Mobile Phone Use, Hiv, Stigma, Social
- Trial name
- In-the-kNOW (NCT05080972)
- Testing
- in-the-kNOW mobile app, Control
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Emory University
Hiv, Minority Stress
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
The overall aim of the research study is to develop and test a mindfulness-based program for young adult gay, bisexual, and queer men at risk for HIV (Brown University IRB approved protocol #2004002698).
- Conditions
- Hiv, Minority Stress, Mental Health Wellness 1
- Trial name
- MBQR (NCT05855655)
- Testing
- Mindfulness-Based Queer Resilience (MBQR)
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV Prevention
Podcasting HIV Prevention Within African American Communities
Given the continued impact of HIV among African Americans, there is still an urgent need to expand prevention efforts and HIV testing in African American communities.
- Trial name
- NCT05365958
- Testing
- HIV Podcast for Heterosexual African American Adults
- Where
- United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- University of Houston
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Delivery System Perceptibility and Acceptability
Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
The purpose of this study is to (a) adapt existing user sensory perception and experience (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs specific to suppository forms for rectal and vaginal…
- Trial name
- DRUM-S (NCT02744261)
- Testing
- Gel, Suppository 1, Suppository 2
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
Human Immunodeficiency Virus (HIV)
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV…
- Trial name
- PEPDar (NCT01516970)
- Testing
- Darunavir/Ritonavir (DRV/r), Lopinavir in fixed combination with Ritonavir, Zidovudine
- Where
- 17 sites in Germany
- Volunteers
- 312 people
- Sponsor
- Janssen-Cilag G.m.b.H
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).
- Trial name
- NCT05243030
- Testing
- Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM), Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Human Immunodeficiency Virus
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT05323123
- Testing
- SPARK, HealthMpowerment, PrEP Education
- Where
- 3 sites in United States, Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University