Assessment of ASPIRE and HOPE Adherence

HIV Prevention Clinical Trial

Official title:

Assessment of ASPIRE and HOPE Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702895
• Other study ID #: MTN-032
• Secondary ID: UM1AI068633UM1AI
• Status: Completed
• Start date: June 13, 2016
• Est. completion date: December 19, 2019

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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

Locations

Country	Name	City	State
Malawi	Malawi Clinical Research Site	Lilongwe
South Africa	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
Uganda	Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site	Kampala
Zimbabwe	Spilhaus Clinical Research Site	Harare
Zimbabwe	Zengeza 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

Malawi,  South Africa,  Uganda,  Zimbabwe, 

References & Publications (3)

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 — View 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. 20 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Perceptions of HIV risk	HIV risk and perceptions of HIV risk in general and specific to participants' and their male partners' motivation to participate in the ASPIRE and/or HOPE trial(s), to use study product (or not) during their participation in ASPIRE and/or HOPE, and male partner support (or lack thereof) of participants' product use in HOPE 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.
Secondary	Product use patterns	Factors influencing product initiation and patterns of use during ASPIRE and/or HOPE 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.
Secondary	Perceptions of various adherence support interventions	Participants' perceptions of various adherence support interventions and engagement activities implemented (or not implemented) during ASPIRE and/or HOPE 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.
Secondary	Understanding of ASPIRE results and ring efficacy	Participants' and their male partners' understanding of the ASPIRE results and ring efficacy, and the impact of this understanding on participants' intention and/or ability to join HOPE and continue in follow-up, on their adherence to the dapivirine VR as part of an open label extension trial as compared to adherence in a Phase 3 safety and effectiveness trial, and male partner support (or lack thereof) of participants' trial participation and product use in HOPE 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.