Clinical Trials Logo
  1. Home
  2. HIV Prevention
  3. NCT02358616

An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial (MTN-003)

HIV Prevention Clinical Trial

Official title:
An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial

Clinical Trial Summary

This study is primarily exploratory and is designed to both identify factors that may have affected participant adherence to study product in VOICE, and describe how sexual behaviors, such as anal sex, may have had an effect on product efficacy. As such there is no specific hypothesis that is being tested.

Clinical Trial Description

MTN-003D will use qualitative in-depth interviews and/or focus group discussions with VOICE participants to explore study product adherence and/or anal sex behaviors in greater depth than was measured quantitatively during trial participation. The study approach is designed to encourage honesty and to minimize socially desirable responses, which may have affected participants' ability/willingness to accurately report during the trial. An in-depth and candid understanding of the various behavioral factors that contribute to the dilution of efficacy may assist in the interpretation of VOICE trial results and inform future studies. In light of VOICE's divergent results, MTN-003D will explore the potential factors that may have contributed to efficacy dilution in the trial. MTN-003D, was initially designed after the early closure of the oral and vaginal tenofovir arms, and sought to explore those factors contributing to the dilution of efficacy using qualitative methods (Stage 1). Given the subsequent release of VOICE results in February of 2013 and the availability of drug PK data, Stage 2 of MTN-003D has been designed to explore factors influencing adherence in greater depth, including HIV risk perception and motivation to join the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02358616
Study type Observational
Source Microbicide Trials Network
Contact
Status Completed
Phase
Start date December 2012
Completion date March 2014
View Details
See also
  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