Clinical trial NCT02358616: An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial (MTN-003)
Official title: An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Prevention
Lead sponsor: Microbicide Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2015-02-09
Enrollment: 219
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former VOICE (MTN-003) participants

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Contextual issues affecting product use
timeFrame: End of Study
Secondary outcomes:
measure: Explore risk perceptions and motivation to join VOICE study
timeFrame: End of Study
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Isipingo Clinical Research Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Overport Clinical Research Site
state: Kwazulu-Natal
city: Kampala
country: Uganda
facility: Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site
city: Harare
country: Zimbabwe
facility: Seke South Clinical Research Site
city: Harare
country: Zimbabwe
facility: Zengeza 3 Clinical Research Site
Study officials:
affiliation: RTI International
name: Ariane van der Straten, PhD
role: STUDY_CHAIR
References:
citation: Simoni JM, Beima-Sofie K, Amico KR, Hosek SG, Johnson MO, Mensch BS. Debrief Reports to Expedite the Impact of Qualitative Research: Do They Accurately Capture Data from In-depth Interviews? AIDS Behav. 2019 Aug;23(8):2185-2189. doi: 10.1007/s10461-018-02387-3.
citation: van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, Hartmann M, Levy L, Bennie T, Cheng H, Piper J, Grossman CI, Marrazzo J, Mensch B; Microbicide Trials Network-003D Study Team. Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS. 2015 Oct 23;29(16):2161-71. doi: 10.1097/QAD.0000000000000801.
citation: Katz AWK, Mensch BS, Woeber K, Musara P, Etima J, van der Straten A. Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence. BMC Womens Health. 2019 Jan 25;19(1):18. doi: 10.1186/s12905-019-0713-6.
citation: Luecke EH, Cheng H, Woeber K, Nakyanzi T, Mudekunye-Mahaka IC, van der Straten A; MTN-003D Study Team. Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. J Int AIDS Soc. 2016 May 30;19(1):20875. doi: 10.7448/IAS.19.1.20875. eCollection 2016.