Skip to main content
OpenTrials
Completed

NCT Number: NCT00405990

Male Partner Involvement in the Prevention of MTCT of HIV

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voluntary counselling and HIV testing in ANC for PMTCT

Behavioral

VCT for 30 minutes in ANC

Other names: ANC VCT, VCT for PMTCT

VCT

Behavioral

HIV VCT for PMTCT

Other names: VCT for PMTCT

Primary outcomes

  1. Percentage of partners agreeing to attend VCT.

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • University of Cape Town

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 4, 2006
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.