HIV Prevention Clinical Trial
Official title:
IGHID 12219 - A Brief Alcohol Reduction Intervention to Reduce Alcohol Use and Improve PrEP Outcomes Among Men Who Have Sex With Men: A Randomized Controlled Trial in Vietnam
The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among men who have sex with men (MSM) with unhealthy alcohol use initiating or re-initiating PrEP in Vietnam.
This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among MSM with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP in Vietnam. The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions. Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48) Study activities will span 5 years. Individual MSM participants will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03411577 -
Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
|
N/A | |
| Active, not recruiting |
NCT03112369 -
Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use
|
N/A | |
| Not yet recruiting |
NCT03642314 -
HIV Self-testing in Implementation PrEP Study
|
N/A | |
| Completed |
NCT01810315 -
Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity
|
Phase 1 | |
| Completed |
NCT00984971 -
Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet
|
Phase 1 | |
| Completed |
NCT00142935 -
Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
|
N/A | |
| Active, not recruiting |
NCT03255915 -
PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)
|
Early Phase 1 | |
| Completed |
NCT05037513 -
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
|
N/A | |
| Recruiting |
NCT05087680 -
An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
|
N/A | |
| Recruiting |
NCT05804461 -
Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico
|
N/A | |
| Completed |
NCT03148171 -
Project WERK (Wellness Encouragement Respect Kinship)
|
N/A | |
| Completed |
NCT04791007 -
OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults
|
Early Phase 1 | |
| Recruiting |
NCT05412433 -
Clinic-based HIV Identification and Prevention Project Using Electronic Resources
|
N/A | |
| Active, not recruiting |
NCT03977181 -
The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms
|
N/A | |
| Recruiting |
NCT05165745 -
Stick2PrEP Cisgender Women and Trans Individuals
|
N/A | |
| Completed |
NCT03719053 -
Single Dose Truvada Study
|
Phase 1 | |
| Recruiting |
NCT03856580 -
Long-acting Biomedical HIV Prevention in Transgender Women
|
N/A | |
| Completed |
NCT02750540 -
Optimization of a Tenofovir Enema for HIV Prevention
|
Phase 1 | |
| Completed |
NCT01386294 -
Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection
|
Phase 3 | |
| Completed |
NCT00993811 -
The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
|
Phase 1 |