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

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Invitation letter for male spouse
Information letter
Sponsored by
Centre For International Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring Prevention of mother-to-child transmission of HIV-1

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mbale Regional Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Invitation letter to male spouse

Information letter

Arm Description

In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit

In this arm the pregnant women got an information letter about antenatal care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2010
Last Updated
January 12, 2013
Sponsor
Centre For International Health
Collaborators
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT01144234
Brief Title
Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda
Acronym
InvolvMaleUg
Official Title
Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre For International Health
Collaborators
Makerere University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Prevention of mother-to-child transmission of HIV-1

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1060 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Invitation letter to male spouse
Arm Type
Experimental
Arm Description
In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
Arm Title
Information letter
Arm Type
Placebo Comparator
Arm Description
In this arm the pregnant women got an information letter about antenatal care.
Intervention Type
Behavioral
Intervention Name(s)
Invitation letter for male spouse
Intervention Description
In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
Intervention Type
Behavioral
Intervention Name(s)
Information letter
Intervention Description
In this arm the pregnant women got an information letter
Primary Outcome Measure Information:
Title
proportion of pregnant women who come with their partners
Description
The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.
Time Frame
follow-up visit 4 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Tumwine, MD, PhD
Organizational Affiliation
Makerere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thorkild Tylleskar, MD, PhD
Organizational Affiliation
Centre for International Health, University of Bergen
Official's Role
Study Chair
Facility Information:
Facility Name
Mbale Regional Referral Hospital
City
Mbale
State/Province
Eastern
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
21914207
Citation
Byamugisha R, Astrom AN, Ndeezi G, Karamagi CA, Tylleskar T, Tumwine JK. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial. J Int AIDS Soc. 2011 Sep 13;14:43. doi: 10.1186/1758-2652-14-43.
Results Reference
result
PubMed Identifier
20573250
Citation
Byamugisha R, Tumwine JK, Semiyaga N, Tylleskar T. Determinants of male involvement in the prevention of mother-to-child transmission of HIV programme in Eastern Uganda: a cross-sectional survey. Reprod Health. 2010 Jun 23;7:12. doi: 10.1186/1742-4755-7-12.
Results Reference
result

Learn more about this trial

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

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