Clinical trial NCT00405990: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
MTCT
heterosexual behaviour
sexual risk behaviour
couple counselling
Voluntary counselling and testing
HIV Seronegativity
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2006-12-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Percentage of partners agreeing to attend VCT.
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Khayelitsha Midwive and Obstetric Unit Site B
state: Western Cape
Study officials:
affiliation: Imperial College London
name: Boshishi K Mohlala, MBCHB FCOG MSC
role: PRINCIPAL_INVESTIGATOR
References:
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.