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