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

NCT01144234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1060

Last updated 2013-01-15

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

BEHAVIORAL

Invitation letter for male spouse

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

BEHAVIORAL

Information letter

In this arm the pregnant women got an information letter

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER
  • Centre For International Health

    lead OTHER

Principal Investigators

  • James K Tumwine, MD, PhD · Makerere University

  • Thorkild Tylleskar, MD, PhD · Centre for International Health, University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144234 on ClinicalTrials.gov