Clinical trials: Oral Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use…
- Trial name
- NCT06394323
- Testing
- Behavioral: My Choice for HIV Prevention (MyChoice)
- Where
- Malawi
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- ADAPT (NCT01327651)
- Testing
- Daily dosing, Time-driven dosing, Event-driven dosing
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Pregnancy, HIV Infections
Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.
- Trial name
- NCT07288190
- Testing
- DPP, 2PR, Free Choice
- Where
- 3 sites in Eswatini, Uganda and 1 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infection
Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India
Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use.
- Trial name
- PrEP-India (NCT02148094)
- Testing
- Truvada
- Where
- 2 sites in India
- Volunteers
- 1,325 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Patient Acceptance of Health Care
Acceptability of HIV Oral PrEP Among MSM and TGW
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).
- Trial name
- NCT02855606
- Where
- Thailand
- Volunteers
- 105 people
- Sponsor
- Chiang Mai University
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: An Implementation Evaluation
The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral…
- Trial name
- NCT06319105
- Testing
- Standard intervention: Offer PrEP choice
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Unsafe Sex, Risk-Taking
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)
The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and…
- Trial name
- DOXYVAC (NCT04597424)
- Testing
- Experimental: doxycycline, Bexsero® vaccine
- Where
- 9 sites in France
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Prevention
Demonstration Project on the Feasibility to Implement PrEP in MSM and TG Women
The purpose of the study is to evaluating the acceptability, use and adherence of a pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered…
- Trial name
- NCT03043326
- Testing
- Tenofovir Disoproxil Fumarate and Emtricitabine
- Where
- 5 sites in Peru
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Asociación Civil Impacta Salud y Educación, Peru
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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 Infections
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either…
- Trial name
- AXIS (NCT06138600)
- Testing
- Cabotegravir Injection [Apretude], Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV
Introducing PrEP Into HIV Combination Prevention - Kenya
Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers (FSWs) and young women (YW) as part of a defined package of HIV combination prevention intervention for 12 months in 5 sites in Kenya.
- Trial name
- IPCP-Kenya (NCT02755350)
- Testing
- Truvada
- Where
- Kenya
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- LVCT Health
HIV Prevention
Supporting Oral and Long-acting PrEP Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about…
- Trial name
- NCT06397690
- Testing
- My Choice for HIV Prevention (MyChoice), Standard of care (control arm)
- Where
- Malawi
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
- Trial name
- NCT02720094
- Testing
- Cabotegravir Oral Tablet, TDF/FTC tablets, CAB LA
- Where
- 43 sites in United States, Argentina and 5 more
- Volunteers
- 4,570 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, PrEP
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC…
- Conditions
- HIV, PrEP, PrEP Adherence
- Trial name
- LYPS (NCT07438041)
- Testing
- LYPS, Enhanced Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Westat
Oral Pre-exposure Prophylaxis (PrEP), Long-acting Injectable Cabotegravir for PrEP
PathToScale: The PERSIST Trial
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis…
- Trial name
- NCT07221747
- Testing
- Standard of Care (SoC), Enhanced continuation support package
- Where
- Malawi
- Volunteers
- 9,900 people, healthy volunteers welcome
- Sponsor
- Georgetown University
HIV Prevention
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when…
- Trial name
- AEGiS (NCT02584140)
- Testing
- Text Messaging, Adherence Counseling, Daily Oral PrEP
- Where
- 5 sites in United States
- Volunteers
- 136 people
- Sponsor
- University of California, Los Angeles
HIV Prevention
The CATALYST Study
The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at…
- Trial name
- NCT05937698
- Where
- 28 sites in Kenya, Lesotho and 3 more
- Volunteers
- 6,069 people, healthy volunteers welcome
- Sponsor
- FHI 360