search
Back to results

Male Partner Involvement in the Prevention of MTCT of HIV

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
South Africa
Study Type
Interventional
Intervention
Voluntary counselling and HIV testing in ANC for PMTCT
VCT
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring HIV, MTCT, heterosexual behaviour, sexual risk behaviour, couple counselling, Voluntary counselling and testing, HIV Seronegativity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

Exclusion Criteria:

  • Women who are more than 30 weeks pregnant will be excluded.

Sites / Locations

  • Khayelitsha Midwive and Obstetric Unit Site B

Outcomes

Primary Outcome Measures

Percentage of partners agreeing to attend VCT.

Secondary Outcome Measures

Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.

Full Information

First Posted
November 30, 2006
Last Updated
May 28, 2015
Sponsor
Imperial College London
Collaborators
University of Cape Town
search

1. Study Identification

Unique Protocol Identification Number
NCT00405990
Brief Title
Male Partner Involvement in the Prevention of MTCT of HIV
Official Title
Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London
Collaborators
University of Cape Town

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.
Detailed Description
We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation. At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic. VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, MTCT, heterosexual behaviour, sexual risk behaviour, couple counselling, Voluntary counselling and testing, HIV Seronegativity

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Voluntary counselling and HIV testing in ANC for PMTCT
Other Intervention Name(s)
ANC VCT, VCT for PMTCT
Intervention Description
VCT for 30 minutes in ANC
Intervention Type
Behavioral
Intervention Name(s)
VCT
Other Intervention Name(s)
VCT for PMTCT
Intervention Description
HIV VCT for PMTCT
Primary Outcome Measure Information:
Title
Percentage of partners agreeing to attend VCT.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment. Exclusion Criteria: Women who are more than 30 weeks pregnant will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boshishi K Mohlala, MBCHB FCOG MSC
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khayelitsha Midwive and Obstetric Unit Site B
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7784
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
21610487
Citation
Mohlala BK, Boily MC, Gregson S. The forgotten half of the equation: randomized controlled trial of a male invitation to attend couple voluntary counselling and testing. AIDS. 2011 Jul 31;25(12):1535-41. doi: 10.1097/QAD.0b013e328348fb85.
Results Reference
derived

Learn more about this trial

Male Partner Involvement in the Prevention of MTCT of HIV

We'll reach out to this number within 24 hrs