Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa

NCT03648931 | Completed

• 5 other identifiers: MTN-041UM1AI068633UM1AI068615UM1AI10670738161
• Study Type: observational
• Target: 232
• Locations: 4 countries
• Sites: 4

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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use

  Focus group discussions and key informant in-depth interviews

  3-6 months during Q2/Q3 2018

• Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use

  Focus group discussions and key informant in-depth interviews

  3-6 months during Q2/Q3 2018

Secondary Outcomes (4)

• Product preferences during pregnancy and breastfeeding

  3-6 months during Q2/Q3 2018

• Sexual activity and contraceptive use during pregnancy and breastfeeding

  3-6 months during Q2/Q3 2018

• Perceptions of HIV risk during pregnancy and breastfeeding

  3-6 months during Q2/Q3 2018

• Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products

  3-6 months during Q2/Q3 2018

Study Arms (4)

Pregnant or Breastfeeding Women

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.

Behavioral: Focus Group Discussion (FGD)

Male Partners

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.

Behavioral: Focus Group Discussion (FGD)

Grandmothers

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.

Behavioral: Focus Group Discussion (FGD)

Key Informants

No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures.

Behavioral: In-depth Interview (IDI)

Interventions

Focus Group Discussion (FGD) BEHAVIORAL

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on: * Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding * Perceptions of HIV risk during pregnancy and breastfeeding * Perceived role of male partners during pregnancy and breastfeeding * Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding * Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding * Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding

Grandmothers; Male Partners; Pregnant or Breastfeeding Women

In-depth Interview (IDI) BEHAVIORAL

No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures, focusing on the following topics: * Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding * Perceptions of HIV risk during pregnancy and breastfeeding * Perceived role of male partners during pregnancy and breastfeeding * Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding * Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding * How others in their professional and social networks and communities would view the VR and/or oral PrEP use by pregnant and breastfeeding women

Key Informants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Able and willing to provide written informed consent in one of the study languages.
• Able and willing to complete the required study procedures.
• For currently or recently pregnant or breastfeeding women:
• Between the ages of 18 to 40 years old (inclusive) at Enrolment, verified per site standard operating procedures (SOPs).
• Currently or recently (within two years) pregnant or breastfeeding (by self-report).
• For male partners:
• Aged 18 years or older at Enrolment, verified per site SOPs.
• Identifies as a primary sexual partner of a woman who is currently or was recently (within two years) pregnant or breastfeeding.
• For grandmothers:
• Aged 18 years or older at Enrolment, verified per site SOPs.
• 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:
• Aged 18 years or older at Enrolment, verified per site SOPs.
• 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.

You may not qualify if:

• 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.
• 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.

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 (4)

Blantyre Clinical Research Site

Blantyre, Malawi

Location

Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site

Johannesburg, South Africa

Location

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site

Kampala, Uganda

Location

Zengeza Clinical Research Site

Harare, Zimbabwe

Location

Related Publications (2)

• 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.

  PMID: 32524700 RESULT

• 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.

  PMID: 33325126 RESULT

Study Officials

• Ariane van der Straten, PhD, MPH

  Women's Global Health Imperative Program, RTI International

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 28, 2018
• Study Start: May 31, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: October 14, 2022

Record last verified: 2021-06

Locations

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