Male Partner Involvement in the Prevention of MTCT of HIV

HIV Infections Clinical Trial

Official title:

Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405990
• Other study ID #: cro625
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2006
• Last updated: May 28, 2015
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Voluntary counselling and HIV testing in ANC for PMTCT
VCT for 30 minutes in ANC
• VCT
HIV VCT for PMTCT

Locations

Country	Name	City	State
South Africa	Khayelitsha Midwive and Obstetric Unit Site B	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of partners agreeing to attend VCT.		12 weeks
Secondary	Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.		12 weeks