Effect of Formal Letter of Invitation on Male Partner Involvement at Antenatal Care Clinic (NCT06171503) | Clinical Trial Compass
CompletedNot Applicable
Effect of Formal Letter of Invitation on Male Partner Involvement at Antenatal Care Clinic
Ethiopia400 participantsStarted 2022-06-22
Plain-language summary
Prevention of mother to child transmission (PMTCT) of human immune deficiency virus (HIV) program requires great male participation in achieving a sustained reduction of mother-to-child transmission of HIV. Many strategies have been employed to promote male participation in antenatal care but few have been assessed to convey important lessons for scale-up. In Ethiopia, though there is no evidence on its effectiveness, letter of invitation has been tried as a means to promote participation of men in PMTCT program at antenatal care. The study is carried out in two public hospitals to evaluate the effect of letter of invitation delivered through mother support group counselling on male involvement at antenatal care clinic.
The findings of this study will directly benefit pregnant women attending antenatal clinic in utilizing PMTCT service effectively. The formal letter of invitation proposed may be incorporated by health service provider in their routine antenatal clinic. It will also help the policy makers to give greater priority to reach and involve men, and to develop effective policies as well as programs to overcome the challenges. Thus, an increase in the uptake of PMTCT services will ultimately lead to a reduction in pediatrics HIV infection.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
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:
* Confirmed pregnancy
* Pregnant women, until 34 weeks gestation. Gestational period is limited to 34 weeks to allow room for suitable evaluation of the strategy as they report for antenatal care
* Pregnant women aged 18 years or older(49) will be eligible
* Marriage or relationship with a woman visited ANC clinic during the study period.
* Pregnant women must be attending antenatal care without a spouse.
* willingness to provide informed consent before study participation
* Planning to attend the antenatal care at the study site on the subsequent visit.
* Permanent residents in intervention and comparison site.
* Partner who is generally accessible (i.e., not permanently working abroad).
* Women should be willing to pass on the invitation letter to their partner whereas in comparison site as she is informed in routine care by antenatal care service provider
* Women has to be normal and expected to follow basic antenatal care
Exclusion Criteria:
* Partner away from his permanent residents' area during data collections period
* Critical ill husband
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
To determine male partner accompany at subsequent antenatal care visit
Timeframe: 2 to 8 weeks
2
To determine male partner HIV testing and counseling