Khayelitsha Midwive and Obstetric Unit Site B
Cape Town, Western Cape, 7784, South Africa
NCT Number: NCT00405990
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.
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Interventional
Phase 4
Cape Town, Western Cape, 7784, South Africa
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VCT for 30 minutes in ANC
Other names: ANC VCT, VCT for PMTCT
HIV VCT for PMTCT
Other names: VCT for PMTCT
Time frame: 12 weeks
Time frame: 12 weeks
Imperial College London
Other
Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.
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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.
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