A Pilot Study of a Voucher Incentive System for Improving Retention in Postpartum HIV Care in South Africa

STUDY DESIGN

This is a prospective intervention cohort study with historical controls. Since this is pilot study to inform a future intervention, up to 200 participants will be enrolled total: up to 100 to receive the intervention and up to 100 historical controls extracted from electronic clinic records. We are using historical controls because we don't feel it is appropriate to randomize vouchers at a site as this will likely cause ill will in the clinic and the clinic was not willing to do this. We also do not have the resources to get data from a second clinic and we felt that given this was a pilot study we would likely increase confounding if we went to another clinic for a comparison group. While the procedure is changing at the clinic to move to Option B+, we do not anticipate being able to begin the actual intervention until late February or March. This will allow for a sufficient number of historical controls to accrue under option B+ to use as a relevant control group. No patient matching will occur.

STUDY SITE Hikhensile Clinic is a primary health care clinic in Region A of Johannesburg, South Africa, operated by the City of Johannesburg Department of Health. Hikhensile primarily serves clients living in Ivory Park (Ward 77) in Midrand.

Hikhensile Clinic offers antenatal and postnatal care, HIV testing and treatment on-site, as well as other primary care services. HIV care is integrated with antenatal care for pregnant women, with assessment for and initiation of ART occurring within antenatal care. HIV testing occurs during a woman's first antenatal visit and, per national guidelines, all pregnant women will be initiated on lifelong antiretroviral therapy (Option B+) as of in January 2015. Hikhensile does not perform deliveries, so all women who receive antenatal care at Hikhensile are designated to deliver at Tembisa Hospital and Ethafeni Hospital. The hospitals do not routinely report delivery information back to Hikhensile. Following delivery, patients return for postnatal care and HIV treatment services at Hikhensile for 10 weeks and then resume general adult care, all within the same facility and using the same clinic file. Mothers and infants make three postnatal care visits together: 3-7 days after delivery; six weeks after delivery for an infant polymerase chain reaction HIV test to determine the HIV status of the baby; and 10 weeks after delivery for infant HIV results.

STUDY POPULATION The study population will consist of up to 200 HIV-positive pregnant women. Up to 100 will be recruited consecutively and enrolled prospectively during routine antenatal care at Hikhensile Clinic in Johannesburg, South Africa. Patient records for up to 100 HIV-positive pregnant women from Hikhensile will be extracted to serve as the historical control group for comparison.