Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda

Study Overview
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Brief Summary
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HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country. Though engaging men as partners is a critical component in the PMTCT programme, their involvement has been low. Measures to increase male partner involvement in the PMTCT programmes have not been explored in Uganda. Objectives: To determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of HIV testing. Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern Uganda Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. The intervention will be a written invitation letter to their spouses. Outcome measures: The main outcome measure is the proportion of pregnant women who come with their partners for ANC at the subsequent antenatal visit. Utility: The results of this study will be utilised in re-orienting the ANC services to encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale Regional Referral Hospital.

Official Title
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Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda

Conditions
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HIV Infection

Intervention / Treatment
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* Behavioral: Invitation letter for male spouse
* Behavioral: Information letter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New antenatal mothers (attendees) at Mbale regional referral hospital Acceptance to attend at least two subsequent antenatal visits at Mbale hospital Exclusion Criteria: Women attending with their spouses at the first ANC visit Refusal to take the letter to her spouse Women with inaccessible spouses

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invitation letter to male spouse<br>In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit | Behavioral: Invitation letter for male spouse<br>* In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit<br>|
| Placebo Comparator: Information letter<br>In this arm the pregnant women got an information letter about antenatal care. | Behavioral: Information letter<br>* In this arm the pregnant women got an information letter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of pregnant women who come with their partners | The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit. | follow-up visit 4 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of mother-to-child transmission of HIV-1