Clinical trial NCT01144234: Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda
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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: Prevention of mother-to-child transmission of HIV-1
Lead sponsor: Centre For International Health
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2010-06-15
Enrollment: 1060
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: proportion of pregnant women who come with their partners
timeFrame: follow-up visit 4 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
state: Eastern
Study officials:
affiliation: Makerere University
name: James K Tumwine, MD, PhD
role: STUDY_CHAIR
affiliation: Centre for International Health, University of Bergen
name: Thorkild Tylleskar, MD, PhD
role: STUDY_CHAIR
References:
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.
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.