Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
302 participants
OBSERVATIONAL
2016-06-13
2019-12-19
Brief Summary
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Detailed Description
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MTN-032, an observational study, using interviews and focus group discussions, is primarily designed to identify factors that may have affected participant adherence to study product in ASPIRE and HOPE, including male partner attitudes. MTN-032 will also elicit perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and may also explore the potential use of incentives to promote adherence to VR use.
MTN-032 will use study product adherence results from ASPIRE and HOPE, qualitative in-depth interviews (IDI) and focus group discussions (FGD) to explore study product adherence behaviors and strategies used to overcome adherence challenges. An in-depth understanding of the various socio-behavioral factors that contribute to product use adherence may assist in the interpretation of past and ongoing study results and inform implementation of future studies.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Phase 1
Former ASPIRE participants
In-depth Interview (IDIs) or Focus Group Discussion (FGD)
Phase 2 HOPE participants
Former HOPE participants
In-depth Interview (IDIs) or Focus Group Discussion (FGD)
Phase 2 Male Partners
Male partners of HOPE participants
In-depth Interview (IDIs) or Focus Group Discussion (FGD)
Interventions
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In-depth Interview (IDIs) or Focus Group Discussion (FGD)
Eligibility Criteria
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Inclusion Criteria
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection.
5. For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available.
1. Participated in the HOPE protocol.
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in HOPE, evidence of study product dispensation for a minimum of three consecutive months.
5. For participants who acquired an HIV infection while taking part in HOPE, evidence of study product dispensation in the month prior to the participant's acquisition of an HIV infection.
1. Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact.
2. Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not).
3. Able and willing to provide written informed consent in one of the study languages.
4. Able and willing to complete the required study procedures.
5. Is above the age of 18 at the time of study participation.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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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)
NIH
Microbicide Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth Montgomery, PhD, MHS
Role: STUDY_CHAIR
RTI International
Locations
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Malawi Clinical Research Site
Lilongwe, , Malawi
Botha's Hill Clinical Research Site
Durban, KwaZulu-Natal, South Africa
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa
Wits Reproductive Health and HIV Institute Clinical Research Site
Johannesburg, , South Africa
Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site
Kampala, , Uganda
Spilhaus Clinical Research Site
Harare, , Zimbabwe
Zengeza Clinical Research Site
Harare, , Zimbabwe
Countries
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References
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Montgomery ET, Stadler J, Naidoo S, Katz AWK, Laborde N, Garcia M, Reddy K, Mansoor LE, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS. 2018 Jul 17;32(11):1517-1525. doi: 10.1097/QAD.0000000000001868.
Naidoo K, Mansoor LE, Katz AWK, Garcia M, Kemigisha D, Morar NS, Zimba CC, Chitukuta M, Reddy K, Soto-Torres L, Naidoo S, Montgomery ET. Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):e90-e96. doi: 10.1097/QAI.0000000000002590.
Montgomery ET, Katz AWK, Duby Z, Mansoor LE, Morar NS, Naidoo K, Tsidya M, Chitukuta M, Guma V, Tenza S, Leslie J, Garcia M, Naidoo S. Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe. AIDS Behav. 2021 Jun;25(6):1890-1900. doi: 10.1007/s10461-020-03119-2. Epub 2021 Jan 2.
Other Identifiers
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Protocol ID#12058
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MTN-032
Identifier Type: -
Identifier Source: org_study_id
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