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

This study has been completed.
Sponsor:
Collaborator:
Makerere University
Information provided by (Responsible Party):
Centre For International Health
ClinicalTrials.gov Identifier:
NCT01144234
First received: June 14, 2010
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
HIV Infection
Behavioral: Invitation letter for male spouse
Behavioral: Information letter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre For International Health:

Primary Outcome Measures:
  • proportion of pregnant women who come with their partners [ Time Frame: follow-up visit 4 weeks later ] [ Designated as safety issue: No ]
    The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.


Enrollment: 1060
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Invitation letter to male spouse
In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
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
Placebo Comparator: Information letter
In this arm the pregnant women got an information letter about antenatal care.
Behavioral: Information letter
In this arm the pregnant women got an information letter

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144234

Locations
Uganda
Mbale Regional Referral Hospital
Mbale, Eastern, Uganda
Sponsors and Collaborators
Centre For International Health
Makerere University
Investigators
Study Chair: James K Tumwine, MD, PhD Makerere University
Study Chair: Thorkild Tylleskar, MD, PhD Centre for International Health, University of Bergen
  More Information

Publications:
Responsible Party: Centre For International Health
ClinicalTrials.gov Identifier: NCT01144234     History of Changes
Other Study ID Numbers: InvolvMaleUg
Study First Received: June 14, 2010
Last Updated: January 12, 2013
Health Authority: Uganda: National Council of Science and Technology

Keywords provided by Centre For International Health:
Prevention of mother-to-child transmission of HIV-1

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2014