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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01144234

Acronym

InvolvMaleUg

Enrollment

1060

Registered

2010-06-15

Start date

2010-06-30

Completion date

2010-12-31

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Prevention of mother-to-child transmission of HIV-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.

Interventions

BEHAVIORALInvitation letter for male spouse

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

BEHAVIORALInformation letter

In this arm the pregnant women got an information letter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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

Design outcomes

Primary

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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026