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Completed

NCT Number: NCT02358616

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

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.

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Key information

Conditions

HIV Prevention

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Isipingo Clinical Research Site, Durban, KwaZulu-Natal, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to perform the study procedures
  • Able and willing to provide informed consent in one of the MTN-003D study languages
  • Participated in VOICE and received at least three consecutive months of study product at any time during VOICE trial participation
  • Stage 2 participants must have pharmacokinetic data available Note: Women from Stage 1 who have PK data available will be considered eligible for Stage 2

Exclusion criteria

  • Has any condition that, in the opinion of the Investigator or Record(IoR)/ designee:
  • would preclude informed consent
  • make study participation unsafe
  • complicate interpretation of study outcome data
  • otherwise interfere with achieving the study objectives.

Treatment and study plan

Primary outcomes

  1. Contextual issues affecting product use

    Time frame: End of Study

    To explore larger contextual issues and specific aspects of the VOICE trial that positively and negatively affected participants' actual and reported product use.

Secondary outcomes

  1. Explore risk perceptions and motivation to join VOICE study

    Time frame: End of Study

    To explore participants' risk perceptions and motivations to participate in VOICE and the association of these factors with product use or non-use in a prevention trial setting.

Sponsors and collaborators

Lead sponsor

Microbicide Trials Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2015
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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