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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

June 14, 2010
January 12, 2013
June 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01144234 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
  • 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
  • Behavioral: Information letter
    In this arm the pregnant women got an information letter
  • 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
    Intervention: Behavioral: Invitation letter for male spouse
  • Placebo Comparator: Information letter
    In this arm the pregnant women got an information letter about antenatal care.
    Intervention: Behavioral: Information letter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1060
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01144234
InvolvMaleUg
No
Centre For International Health
Centre For International Health
Makerere University
Study Chair: James K Tumwine, MD, PhD Makerere University
Study Chair: Thorkild Tylleskar, MD, PhD Centre for International Health, University of Bergen
Centre For International Health
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP