Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda
InvolvMaleUg
Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda
1 other identifier
interventional
1,060
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 15, 2013
January 1, 2013
6 months
June 14, 2010
January 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Invitation letter to male spouse
EXPERIMENTALIn this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
Information letter
PLACEBO COMPARATORIn this arm the pregnant women got an information letter about antenatal care.
Interventions
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
Eligibility Criteria
You may qualify if:
- New antenatal mothers (attendees) at Mbale regional referral hospital
- Acceptance to attend at least two subsequent antenatal visits at Mbale hospital
You may not qualify if:
- Women attending with their spouses at the first ANC visit
- Refusal to take the letter to her spouse
- Women with inaccessible spouses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre For International Healthlead
- Makerere Universitycollaborator
Study Sites (1)
Mbale Regional Referral Hospital
Mbale, Eastern Region, Uganda
Related Publications (2)
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.
PMID: 21914207RESULTByamugisha 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.
PMID: 20573250RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James K Tumwine, MD, PhD
Makerere University
- STUDY CHAIR
Thorkild Tylleskar, MD, PhD
Centre for International Health, University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2010
First Posted
June 15, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 15, 2013
Record last verified: 2013-01