Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda (InvolveMaleUg)
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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, 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 |
- 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.
| Estimated 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 |
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| Uganda | |
| Mbale Regional Referral Hospital | |
| Mbale, Eastern, Uganda | |
| Study Chair: | James K Tumwine, MD, PhD | Makerere University |
| Study Chair: | Thorkild Tylleskar, MD, PhD | Centre for International Health, University of Bergen |
More Information
No publications provided by Centre For International Health
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Robert Byamugisha, Mbale Regional Hospital, Mbale, Uganda |
| ClinicalTrials.gov Identifier: | NCT01144234 History of Changes |
| Other Study ID Numbers: | InvolveMaleUg |
| Study First Received: | June 14, 2010 |
| Last Updated: | March 13, 2011 |
| 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 October 17, 2012
