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

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358616
• Other study ID #: MTN-003D
• Secondary ID: 5UM1AI0686331189
• Status: Completed
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2021
• Source: Microbicide Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Locations

Country	Name	City	State
South Africa	Isipingo Clinical Research Site	Durban	KwaZulu-Natal
South Africa	Overport Clinical Research Site	Durban	Kwazulu-Natal
Uganda	Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site	Kampala
Zimbabwe	Seke South Clinical Research Site	Harare
Zimbabwe	Zengeza 3 Clinical Research Site	Harare

Sponsors (4)

Lead Sponsor	Collaborator
Microbicide Trials Network	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)

Countries where clinical trial is conducted

South Africa,  Uganda,  Zimbabwe, 

References & Publications (2)

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/s10461-018-02 — View 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 understa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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