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NCT Number: NCT01144234

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbale Regional Referral Hospital

Mbale, Eastern Region, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invitation letter for male spouse

Behavioral

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

Information Letter

Behavioral

In this arm the pregnant women got an information letter

Primary outcomes

  1. proportion of pregnant women who come with their partners

    Time frame: follow-up visit 4 weeks later

    The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.

Sponsors and collaborators

Lead sponsor

Centre For International Health

Other

Collaborators

  • Makerere University

Registry information

Official study 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

Acronym: InvolvMaleUg

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2010
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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