Primary Outcome Measures:
- HIV-free survival among HIV-exposed infants. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Our primary outcome will be HIV-free survival at 18 months among HIV-exposed infants. HIV-free survival has been proposed as a more comprehensive measure of PMTCT program effectiveness than HIV infections alone, since health services may have a broader health impact outside of interrupted transmission. We have chosen the 18-month time point for several reasons. Because the vast majority of HIV-exposed infants will have stopped breastfeeding by this age, this will provide more complete ascertainment of mother-to-child transmission compared to earlier measurements. This time point has also been endorsed by the WHO as one of two priority outcomes for PMTCT impact evaluations. Since both methodologies will sample and recruit participants from within the community, our measures will be population-based (vs. facility-based).
We will collect Dried Blood Specimens (DBS) from both mother and infant and link them using pre-printed bar codes. For a mother who refuses real-time testing, but agrees to collection of this maternal DBS specimen, she will be provided a card with a unique study-generated identification number that can be used pick-up results at the community's designated health facility. For those who agreed to on-site HIV testing, we will retain the DBS specimens for quality assurance purposes. As part of the informed consent process, participants will also be asked whether leftover specimens may be used for future use, pending local and international ethical approvals for specified substudies.