Clinical trial NCT03648931: Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa
Official title: Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding
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: 2018-08-28
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The MTN-041 study population will consist of HIV-uninfected women 18-40 years old who are currently or were recently (within two years) pregnant or breastfeeding, men aged 18 years or older whose partners are currently or were recently (within two years) pregnant or breastfeeding, grandmothers whose daughters or daughters-in-law are currently or were recently (within two years) pregnant or breastfeeding, and key informants (KIs), which include: health care providers (HCPs), traditional birth attendants (TBAs), providers of family planning, antenatal, and traditional health services to women, providers of other social services to women, and community leaders.

Brief summary: The MTN-041 study is a multi-site exploratory study using focus group discussions (FGDs) and in-depth interviews (IDIs) to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly dapivirine (DPV) vaginal ring (VR) and daily oral pre-exposure prophylaxis (PrEP), by pregnant and breastfeeding women in Africa.

Detailed description: MTN-041 is an exploratory study primarily designed to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly DPV VR and daily oral PrEP, in a vulnerable yet seldom-studied population, pregnant and breastfeeding women. MTN-041 will utilize FGDs and IDIs to elicit community and health professional perceptions about vaginal practices, sexual activity, use of medicines, and HIV risk during pregnancy or breastfeeding, including how these perceptions may affect pregnant and breastfeeding women's acceptability of using intravaginal products and oral medications like the DPV VR and Truvada oral tablet.

The MTN-041 study population will consist of HIV-uninfected women 18-40 years old who are currently or were recently (within two years) pregnant or breastfeeding, men aged 18 years or older whose partners are currently or were recently (within two years) pregnant or breastfeeding, grandmothers whose daughters or daughters-in-law are currently or were recently (within two years) pregnant or breastfeeding, and key informants (KIs), which include: health care professionals (HCPs), traditional birth attendants (TBAs), providers of family planning, antenatal, and traditional health services to women, providers of other social services to women, and community leaders.

Up to 60 men and women will be selected at each site for participation in this study, for a maximum total of 240 study participants. This includes up to 50 FGD participants (currently or recently pregnant or breastfeeding women, male partners of women who are currently or were recently pregnant or breastfeeding, and grandmothers with currently or recently pregnant or breastfeeding daughters/daughters-in-law) and up to 10 KIs selected at each site, for a maximum total of 200 FGD participants and 40 KIs enrolled across all sites.

Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide written informed consent in one of the study languages.
2. Able and willing to complete the required study procedures.

   For currently or recently pregnant or breastfeeding women:
3. Between the ages of 18 to 40 years old (inclusive) at Enrolment, verified per site standard operating procedures (SOPs).
4. Currently or recently (within two years) pregnant or breastfeeding (by self-report).

   For male partners:
5. Aged 18 years or older at Enrolment, verified per site SOPs.
6. Identifies as a primary sexual partner of a woman who is currently or was recently (within two years) pregnant or breastfeeding.

   For grandmothers:
7. Aged 18 years or older at Enrolment, verified per site SOPs.
8. Identifies as the maternal or paternal grandmother of a daughter or daughter-in-law who is currently or was recently (within two years) pregnant or breastfeeding.

   Note: The term "daughter-in-law" includes women who are/were not married to their male partner during or after pregnancy.

   For service provider KIs:
9. Aged 18 years or older at Enrolment, verified per site SOPs.
10. Currently working as a clinician (e.g., obstetrician, nurse, pharmacist, etc.), traditional care provider (e.g., TBA, healer, midwife, etc.), social service provider (e.g., social worker, family planning counselor, etc.) or community health worker in one of the study countries, verified per site SOPs.
11. Experienced in providing services to pregnant and/or breastfeeding women.

    For community leader KIs:
12. Aged 18 years or older at Enrolment, verified per site SOPs.
13. Currently acting in a community leadership role (e.g., local chief, religious leader, etc.).

Exclusion Criteria:

1. Has any 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.
2. For currently or recently pregnant or breastfeeding women: known HIV-positive status, verified per recent health record (e.g., health passport, ante-natal book, HIV test card, or similar document) or by self-report if health record(s) not available.

Primary outcomes:
measure: Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use
timeFrame: 3-6 months during Q2/Q3 2018
measure: Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use
timeFrame: 3-6 months during Q2/Q3 2018
Secondary outcomes:
measure: Product preferences during pregnancy and breastfeeding
timeFrame: 3-6 months during Q2/Q3 2018
measure: Sexual activity and contraceptive use during pregnancy and breastfeeding
timeFrame: 3-6 months during Q2/Q3 2018
measure: Perceptions of HIV risk during pregnancy and breastfeeding
timeFrame: 3-6 months during Q2/Q3 2018
measure: Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products
timeFrame: 3-6 months during Q2/Q3 2018
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Blantyre Clinical Research Site
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site
city: Kampala
country: Uganda
facility: Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
city: Harare
country: Zimbabwe
facility: Zengeza Clinical Research Site
Study officials:
affiliation: Women's Global Health Imperative Program, RTI International
name: Ariane van der Straten, PhD, MPH
role: STUDY_CHAIR
References:
citation: van der Straten A, Ryan JH, Reddy K, Etima J, Taulo F, Mutero P, Taylor J, Piper J, Musara P; MTN-041/MAMMA Study Team. Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study. J Int AIDS Soc. 2020 Jun;23(6):e25536. doi: 10.1002/jia2.25536.
citation: Flax VL, Hawley I, Ryan J, Chitukuta M, Mathebula F, Nakalega R, Seyama L, Taulo F, van der Straten A; MTN-041/MAMMA Study Team. After their wives have delivered, a lot of men like going out: Perceptions of HIV transmission risk and support for HIV prevention methods during breastfeeding in sub-Saharan Africa. Matern Child Nutr. 2021 Apr;17(2):e13120. doi: 10.1111/mcn.13120. Epub 2020 Dec 15.