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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02358616

Enrollment

219

Registered

2015-02-09

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Contextual issues affecting product use	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

Measure	Time frame	Description
Explore risk perceptions and motivation to join VOICE study	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.

Countries

South Africa, Uganda, Zimbabwe

Outcome results