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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Prevention

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Former VOICE (MTN-003) participants<br>Qualitative interviews and focus group discussions conducted on former VOICE participants. All participants to receive interviews. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contextual issues affecting product use | To explore larger contextual issues and specific aspects of the VOICE trial that positively and negatively affected participants' actual and reported product use. | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore risk perceptions and motivation to join VOICE 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. | End of Study |