Assessment of ASPIRE and HOPE Adherence

NCT02702895 | Completed

• 5 other identifiers: MTN-032UM1AI068633UM1AI068615UM1AI106707Protocol ID#12058
• Study Type: observational
• Target: 302
• Locations: 4 countries
• Sites: 7

Brief Summary

MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner attitudes towards and experiences with the dapivirine VR and their perspective of their female partner's attitudes and experiences.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Factors affecting product use adherence

  Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD.

  Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

• Male partner attitudes affecting product use adherence

  male partner attitudes towards and experiences with the dapivirine VR, and their perspective of their female partner's attitudes and experienceswill be captured by FGD and/or IDI.

  Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

Secondary Outcomes (4)

• Perceptions of HIV risk

  Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

• Product use patterns

  Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

• Perceptions of various adherence support interventions

  Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

• Understanding of ASPIRE results and ring efficacy

  Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.

Study Arms (3)

Phase 1

Former ASPIRE participants

Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)

Phase 2 HOPE participants

Former HOPE participants

Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)

Phase 2 Male Partners

Male partners of HOPE participants

Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)

Interventions

In-depth Interview (IDIs) or Focus Group Discussion (FGD) BEHAVIORAL

Phase 1; Phase 2 HOPE participants; Phase 2 Male Partners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample of 187 former ASPIRE participants was selected to take part in Phase 1 of the study. A sample of up to 156 HOPE participants will be selected for participation in Phase 2. In addition, a sample of up to 120 male partners of HOPE participants who provided consent to have their male partners contacted will be selected for participation in Phase 2. Participants will all be adult women and their adult male partners from seven sites in three African countries: South Africa, Uganda and Malawi. It is anticipated that participants and their male partners will be representative of the overall ASPIRE and HOPE trials by enrolling participants from each of the participating ASPIRE and HOPE countries.

You may qualify if:

• Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment.
• Able and willing to provide written informed consent in one of the study languages.
• Able and willing to complete the required study procedures.
• 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.
• 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.
• Participated in the HOPE protocol.
• Able and willing to provide written informed consent in one of the study languages.
• Able and willing to complete the required study procedures.
• 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.
• 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.
• Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact.
• Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not).
• Able and willing to provide written informed consent in one of the study languages.
• Able and willing to complete the required study procedures.
• Is above the age of 18 at the time of study participation.

You may not qualify if:

• \. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Sponsors & Collaborators

• Microbicide Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (7)

Malawi Clinical Research Site

Lilongwe, Malawi

Location

Botha's Hill Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

Wits Reproductive Health and HIV Institute Clinical Research Site

Johannesburg, South Africa

Location

Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site

Kampala, Uganda

Location

Spilhaus Clinical Research Site

Harare, Zimbabwe

Location

Zengeza Clinical Research Site

Harare, Zimbabwe

Location

Related Publications (3)

• 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.

  PMID: 29957723 RESULT

• 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.

  PMID: 33278181 RESULT

• 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.

  PMID: 33389318 RESULT

Study Officials

• Elizabeth Montgomery, PhD, MHS

  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: August 31, 2015
• First Posted: March 9, 2016
• Study Start: June 13, 2016
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2019
• Last Updated: October 13, 2022

Record last verified: 2021-06

Locations

ZI (2); UG (1); MA (1); ZA (3)