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Clinical Trials

MainTitle

Male Partner Involvement in the Prevention of MTCT of HIV

This study has been completed
Sponsor
Imperial College London

Collaborator
University of Cape Town

Information provided by (Responsible Party)
Imperial College London
ClinicalTrials.gov Identifier
NCT00405990

First received: November 30, 2006
Last updated: May 28, 2015
Last Verified: May 2008
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Behavioral : Voluntary counselling and HIV testing in ANC for PMTCT
Behavioral : VCT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.

Further study details as provided by Imperial College London:

Primary Outcome Measures

  • Percentage of partners agreeing to attend VCT. [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
  • Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently. [ Time Frame: 12 weeks ]

Enrollment: 1000
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405990

Locations

South Africa
Khayelitsha Midwive and Obstetric Unit Site B
Cape Town, Western Cape, South Africa, 7784

Sponsors and Collaborators

Imperial College London
University of Cape Town

Investigators

Principal Investigator: Boshishi K Mohlala, MBCHB FCOG MSC Imperial College London
More Information

More Information


Responsible Party: Imperial College London  
ClinicalTrials.gov Identifier: NCT00405990   History of Changes  
Other Study ID Numbers: cro625  
Study First Received: November 30, 2006  
Last Updated: May 28, 2015  

Keywords provided by Imperial College London:

HIV
MTCT
heterosexual behaviour
sexual risk behaviour
couple counselling
Voluntary counselling and testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.