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

HIV Infection Clinical Trial

— InvolvMaleUg  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144234
• Other study ID #: InvolvMaleUg
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: January 12, 2013
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: Centre For International Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infection

Intervention

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
• Information letter
In this arm the pregnant women got an information letter

Locations

Country	Name	City	State
Uganda	Mbale Regional Referral Hospital	Mbale	Eastern

Sponsors (2)

Lead Sponsor	Collaborator
Centre For International Health	Makerere University

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

Byamugisha R, Åstrøm AN, Ndeezi G, Karamagi CA, Tylleskär 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. — View Citation

Byamugisha R, Tumwine JK, Semiyaga N, Tylleskär 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: 10.1186/1742-4755-7-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of pregnant women who come with their partners	The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.	follow-up visit 4 weeks later	No