Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa (NCT03648931) | Clinical Trial Compass
CompletedNot Applicable
Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa
Malawi, South Africa, Uganda232 participantsStarted 2018-05-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Identifies as a primary sexual partner of a woman who is currently or was recently (within two years) pregnant or breastfeeding.
. Aged 18 years or older at Enrolment, verified per site SOPs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use
. 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.
Exclusion criteria
. 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.