Effect of Formal Letter of Invitation on Male Partner Involvement at Antenatal Care Clinic

NCT06171503 | Completed

• 1 other identifier: IHRPGD/549/21
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Male Reproductive Problem

Outcome Measures

Primary Outcomes (2)

• To determine male partner accompany at subsequent antenatal care visit

  proportion of pregnant women that are accompanied by their partners at week2 and week 8 in the intervention and comparison group

  2 to 8 weeks

• To determine male partner HIV testing and counseling

  proportion of male partners taking up of HIV testing and counselling in both intervention and comparison groups at week 2 and week 8 based on the new WHO ANC model

  2 to 8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

participants on intervention group will receive letter of invitation to invite her partner to attend antenatal care clinic on subsequent visit 2 to 8 weeks

Behavioral: letter of invitation on MI in PMTCT service

comparison group

NO INTERVENTION

participant on comparison group do not receive a letter but will receive routine care to attend antenatal care along with her partner on subsequent visit 2 to 8 weeks

Interventions

letter of invitation on MI in PMTCT service BEHAVIORAL

A non randomized control trial for the total of six month duration will be employed: the first phase is base line survey (pretest) to determine the magnitude of MI and qualitative method using FGD, IDI and KI with selected group to complement the base line will be conducted. Phase 2 Simultaneously with base line, the intervention will be employed to evaluate the effectiveness of invitation letter through mother support group to pregnant women attending antenatal clinic with out her partner as a strategy for male involvement in PMTCT/ANC services. End line data using qualitative approaches will be collected from partners attending antenatal care clinic following letter of invitation to evaluate the effectiveness of letter of invitation.

intervention group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Partner away from his permanent residents' area during data collections period
• Critical ill husband

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Goba genera hospital

Goba, Oromiya, 302, Ethiopia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture at Madda Walabu University (MPH in RH)

Model Details: A non randomized control trial is conducted to see the effect of letter of invitation on promoting male involvement in PMTCT service. Pregnant women visiting antenatal care clinic with out their partners will be enrolled for the intervention and receive letter of invitation from mother support group to invite their partners on subsequent visit at ANC clinic while pregnant woman visiting ANC clinic with out their partners on comparison group will not receive letter and continue to take the usual care and appointed for their next visit

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: June 22, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)