Male Partner Involvement in the Prevention of MTCT of HIV
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|ClinicalTrials.gov Identifier: NCT00405990|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Voluntary counselling and HIV testing in ANC for PMTCT Behavioral: VCT||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||May 2008|
- Behavioral: Voluntary counselling and HIV testing in ANC for PMTCT
VCT for 30 minutes in ANCOther Names:
- ANC VCT
- VCT for PMTCT
- Behavioral: VCT
HIV VCT for PMTCTOther Name: VCT for PMTCT
- Percentage of partners agreeing to attend VCT. [ Time Frame: 12 weeks ]
- Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405990
|Khayelitsha Midwive and Obstetric Unit Site B|
|Cape Town, Western Cape, South Africa, 7784|
|Principal Investigator:||Boshishi K Mohlala, MBCHB FCOG MSC||Imperial College London|