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Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa (MAMMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648931
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Microbicide Trials Network

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.

Condition or disease Intervention/treatment
HIV Prevention Behavioral: Focus Group Discussion (FGD) Behavioral: In-depth Interview (IDI)

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.

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Study Type : Observational
Actual Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)

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

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)

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
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)

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

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)

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




Primary Outcome Measures :
  1. Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews

  2. Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews


Secondary Outcome Measures :
  1. Product preferences during pregnancy and breastfeeding [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews

  2. Sexual activity and contraceptive use during pregnancy and breastfeeding [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews

  3. Perceptions of HIV risk during pregnancy and breastfeeding [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews

  4. Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products [ Time Frame: 3-6 months during Q2/Q3 2018 ]
    Focus group discussions and key informant in-depth interviews



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648931


Locations
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Malawi
Blantyre Clinical Research Site
Blantyre, Malawi
South Africa
Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site
Johannesburg, South Africa
Uganda
Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
Kampala, Uganda
Zimbabwe
Zengeza Clinical Research Site
Harare, Zimbabwe
Sponsors and Collaborators
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Ariane van der Straten, PhD, MPH Women's Global Health Imperative Program, RTI International

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Responsible Party: Microbicide Trials Network
ClinicalTrials.gov Identifier: NCT03648931    
Other Study ID Numbers: MTN-041
UM1AI068633 ( U.S. NIH Grant/Contract )
UM1AI068615 ( U.S. NIH Grant/Contract )
UM1AI106707 ( U.S. NIH Grant/Contract )
38161 ( Other Identifier: DAIDS )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No