NCT02358616

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

September 5, 2013

Last Update Submit

June 17, 2021

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Explore risk perceptions and motivation to join VOICE study

    End of Study

Study Arms (1)

Former VOICE (MTN-003) participants

Qualitative interviews and focus group discussions conducted on former VOICE participants. All participants to receive interviews.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Former VOICE (MTN-003) participants

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Isipingo Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

Overport Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site

Kampala, Uganda

Location

Seke South Clinical Research Site

Harare, Zimbabwe

Location

Zengeza 3 Clinical Research Site

Harare, Zimbabwe

Location

Related Publications (4)

  • 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.

    PMID: 30666522RESULT

  • 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.

    PMID: 26544581RESULT

  • 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.

    PMID: 30683103DERIVED

  • 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.

    PMID: 27247202DERIVED

Study Officials

  • Ariane van der Straten, PhD

    RTI International

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

February 9, 2015

Study Start

December 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

ZI(2)ZA(2)UG(1)