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| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1AI068633 | U.S. NIH Grant/Contract | View source | |
| 11893 | Other Grant/Funding Number | DAIDS Protocol ID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Mental Health (NIMH) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Former VOICE (MTN-003) participants | Qualitative interviews and focus group discussions conducted on former VOICE participants. All participants to receive interviews. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Has any condition that, in the opinion of the Investigator or Record(IoR)/ designee:
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Former VOICE (MTN-003) participants
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| Name | Affiliation | Role |
|---|---|---|
| Ariane van der Straten, PhD | RTI International | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isipingo Clinical Research Site | Durban | KwaZulu-Natal | South Africa | |||
| Overport Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30666522 | Result | 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. | |
| 26544581 | Result | 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. |
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| Durban |
| KwaZulu-Natal |
| South Africa |
| Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site | Kampala | Uganda |
| Seke South Clinical Research Site | Harare | Zimbabwe |
| Zengeza 3 Clinical Research Site | Harare | Zimbabwe |
| 30683103 | Derived | 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. |
| 27247202 | Derived | 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. |