HIV PreventionMAMMANCT03648931
Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa
An observational study of HIV Prevention, run by Microbicide Trials Network at 4 sites in 4 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Focus Group Discussion (FGD) and In-depth Interview (IDI)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 232 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 31 May 2018to 2 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
- Experienced in providing services to pregnant and/or breastfeeding women.
- For community leader KIs:
- Aged 18 years or older at Enrolment, verified per site SOPs.
- Currently acting in a community leadership role (e.g., local chief, religious leader, etc.).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
South Africa1 site
Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site
Johannesburg
Uganda1 site
Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
Kampala
About this study
Official title: Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding
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.
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- Focus Group Discussion (FGD), In-depth Interview (IDI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group Discussion (FGD)Behavioural
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
In-depth Interview (IDI)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: In-depth Interview (IDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3-6 months during Q2/Q3 2018
Secondary outcomes (4)
Product preferences during pregnancy and breastfeeding
Focus group discussions and key informant in-depth interviews
Measured: 3-6 months during Q2/Q3 2018
Sexual activity and contraceptive use during pregnancy and breastfeeding
Focus group discussions and key informant in-depth interviews
Measured: 3-6 months during Q2/Q3 2018
Perceptions of HIV risk during pregnancy and breastfeeding
Focus group discussions and key informant in-depth interviews
Measured: 3-6 months during Q2/Q3 2018
Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products
Focus group discussions and key informant in-depth interviews
Measured: 3-6 months during Q2/Q3 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start31 May 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbicide Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ariane van der Straten, PhD, MPH, Study chair, Women's Global Health Imperative Program, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648931
- Sponsor's protocol ID
- MTN-041
- Other IDs
- UM1AI068633, UM1AI068615, UM1AI106707, 38161
- Acronym
- MAMMA
- Status last verified
- Jun 2021
- First submitted
- 2 Aug 2018
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32524700Flax 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.
PubMed 33325126
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding
- ClinicalTrials.gov ID
- NCT03648931
- Acronym / sponsor ID
- MAMMA / MTN-041
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Microbicide Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant or Breastfeeding Women | – | 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. |
| Male Partners | – | 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. |
| Grandmothers | – | 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. |
| Key Informants | – | Behavioral: In-depth Interview (IDI)No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (19 listed)
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- 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).
- Aged 18 years or older at Enrolment, verified per site SOPs.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Grandmothers, Male Partners, Pregnant or Breastfeeding Women |
| 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 | Behavioural | Key Informants |
Primary outcome
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
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
4 secondary outcomes
Product preferences during pregnancy and breastfeeding
Time frame: 3-6 months during Q2/Q3 2018
Sexual activity and contraceptive use during pregnancy and breastfeeding
Time frame: 3-6 months during Q2/Q3 2018
Perceptions of HIV risk during pregnancy and breastfeeding
Time frame: 3-6 months during Q2/Q3 2018
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Results publication: PubMed 32524700van 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.
- Results publication: PubMed 33325126Flax 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane van der Straten, PhD, MPH study chair
Women's Global Health Imperative Program, RTI International
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by Microbicide Trials Network at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malawi, South Africa, Uganda, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.