Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial.

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394).

Retention in HIV Care Among HIV-Seropositive Pregnant and Postpartum Women in Uganda: Results of a Randomized Controlled Trial.

We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes. 133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1 month, and were then randomized to receive text message reminders (triggered by late dose-taking) and data-informed counseling through 3 months postpartum or standard care. We assessed "full retention" (proportion attending all monthly clinic visits and delivering at a study facility; "visit retention" (proportion of clinic visits attended); and "postpartum retention" (proportion retained at 3 months postpartum). Intention-to-treat and per protocol analyses found that retention was relatively low and similar between groups, with no significant differences. Retention declined significantly post-delivery. The intervention was unsuccessful in this population, which experiences suboptimal ART retention and is in urgent need of effective interventions.

Impact of a Maternal Prevention of Mother-to-child Transmission of HIV (PMTCT) Intervention on HIV-exposed Infants in Uganda.

BACKGROUND: Uganda has successfully reduced pediatric HIV infections through prevention of mother-to-child transmission of HIV (PMTCT) programs, yet little is known about adherence to infant-specific components of interventions. We hypothesized that infants born to mothers receiving the WiseMama (WM) electronic drug monitoring (EDM)-based adherence intervention would have increased uptake of six-week post-natal nevirapine (NVP) infant prophylaxis and better adherence to six-week early infant diagnosis (EID) HIV testing. METHODS: At two sites in Uganda, the Wise Infant Study (WIN) prospectively followed an infant cohort. Infants were born to women enrolled in an RCT testing the effect of real-time reminders delivered via EDM on maternal adherence to antiretroviral therapy. We assessed intrapartum and discharge receipt of NVP prophylaxis using pharmacy and infant HIV DNA testing laboratory data. RESULTS: Of 121 women eligible for WIN, 97 (80%) consented and enrolled; 46 had been randomized to control and 51 to intervention. There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53). Receipt of any NVP prophylaxis did not vary by delivery location (p = 0.35), and although 12% of infants were delivered at non-study health facilities, they were not less likely to receive NVP at discharge (p = 0.37). Among infants with a completed HIV test, there was no difference in mean time to first test (control 52 days (SD 18), intervention 51 days (SD 15), p = 0.86). Only one infant, in the control group, tested positive for HIV. CONCLUSION AND GLOBAL HEALTH IMPLICATIONS: We found no significant differences in adherence to infant PMTCT practices between intervention and control infants with relatively high rates of NVP receipt albeit with suboptimal adherence to six-week EID testing. Further work is needed to ensure improved access, uptake, and follow-up of HIV-exposed infants in the Option B+ era.