Clinical trial NCT02702895: Assessment of ASPIRE and HOPE Adherence
Official title: Assessment of ASPIRE and HOPE Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Prevention
Lead sponsor: Microbicide Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2016-03-09
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: The MTN-032 trial is a two-phase exploratory sub-study of the ASPIRE and HOPE trials. A total of 187 former ASPIRE participants aged 19-48 years were enrolled in Phase 1 of this study. Up to 156 HOPE participants and up to 120 male partners of HOPE participants will be selected for participation in Phase 2 of this study. There were approximately 4-6 months allotted for recruitment and follow-up at each site for Phase 1, and 9-12 months allotted for recruitment and follow-up at each site for Phase 2..

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.

Eligibility criteria: Inclusion Criteria (Phase 1 - Former ASPIRE participants):

1. Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment.
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.

Inclusion Criteria (Phase 2 - HOPE participants):

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.

Inclusion Criteria (Phase 2 - Male partners of HOPE participants):

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 (Phase 1 and Phase 2):

1. 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.

Primary outcomes:
measure: Factors affecting product use adherence
timeFrame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
measure: Male partner attitudes affecting product use adherence
timeFrame: Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary outcomes:
measure: Perceptions of HIV risk
timeFrame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
measure: Product use patterns
timeFrame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
measure: Perceptions of various adherence support interventions
timeFrame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
measure: Understanding of ASPIRE results and ring efficacy
timeFrame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Malawi Clinical Research Site
city: Durban
country: South Africa
facility: Botha's Hill Clinical Research Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site
state: KwaZulu-Natal
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute Clinical Research Site
city: Kampala
country: Uganda
facility: Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site
city: Harare
country: Zimbabwe
facility: Spilhaus Clinical Research Site
city: Harare
country: Zimbabwe
facility: Zengeza Clinical Research Site
Study officials:
affiliation: RTI International
name: Elizabeth Montgomery, PhD, MHS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.