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

Centre For International Health

Status: Completed

Conditions: HIV Infection

Treatments: Behavioral: Information letter; Behavioral: Invitation letter for male spouse

Study type: Interventional

Funder types: Other

Identifiers

NCT01144234

InvolvMaleUg

Details and patient eligibility

About

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.

Enrollment: 1,060 patients

Sex: All

Ages: 15+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,060 participants in 2 patient groups, including a placebo group

Invitation letter to male spouse

Experimental group

Description:

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

Treatment:

Behavioral: Invitation letter for male spouse

Information letter

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Information letter