Impact of Point-of-Care CD4 Testing on Retention in Care Among HIV-Positive Pregnant and Breastfeeding Women in the Context of Option B+ in Zimbabwe: A Cluster Randomized Controlled Trial.

INTRODUCTION: Scale-up of Option B+ in Zimbabwe has increased antiretroviral therapy (ART) coverage but patient loss-to-follow-up remains high; thus, effective strategies to improve retention in care are needed. Evidence for Elimination, a cluster randomized controlled trial, evaluated the impact of point-of-care (POC) CD4 testing with CD4 count-specific adherence counseling on rates of retention among 1150 HIV-positive pregnant women initiating ART in Zimbabwe. METHODS: Thirty-two primary care health facilities were randomized to offer either standard-of-care (SOC) or POC CD4 testing plus CD4-specific counseling to clients (POC Plus). The primary outcome was the proportion of HIV-positive pregnant women retained on ART after 12 months, calculated by cluster-adjusted proportions, unadjusted and adjusted relative risks (RR and aRR, respectively). RESULTS: Retention in care 12 months after initiation was 50.7% and 54.5% in the POC Plus and SOC arms, respectively (RR 0.93, 95% confidence interval [CI]: 0.78 to 1.11; aRR 0.91, 95% CI: 0.77 to 1.07). Although considered not retained, 9.7% transferred to another facility and 0.2% died. Most women, 95.3% in POC Plus and 92.9% in SOC, initiated ART within 1 month of antenatal booking (RR 1.03, 95% CI: 0.97 to 1.08). DISCUSSION: Although patient retention was similar in both arms, women in the POC Plus arm were more likely to have received a CD4 test at booking and a repeat CD4 test later in care. CD4 is no longer required for treatment initiation but is still recommended in national guidelines and is of value in clinical management. Further work is needed to identify effective strategies to increase patient retention in ART care.

Patterns of HIV Care Clinic Attendance and Adherence to Antiretroviral Therapy Among Pregnant and Breastfeeding Women Living With HIV in the Context of Option B+ in Zimbabwe.

BACKGROUND: Consistent use of antiretroviral therapy (ART) during pregnancy and breastfeeding reduces the likelihood of mother-to-child HIV transmission. All pregnant and breastfeeding women living with HIV in Zimbabwe are offered ART with same-day initiation regardless of CD4 count (Option B+). We investigated patterns of clinic attendance and adherence to ART among HIV-infected pregnant women in Zimbabwe. METHODS: The Evidence for Elimination cluster-randomized trial evaluating point-of-care CD4 testing included 1150 HIV-infected ART-naive women attending antenatal care between January 2014 and June 2015. Thirty-two primary care facilities were randomized between 2 arms. In this secondary analysis of Evidence for Elimination data collected from routine clinic records, we classified women by number of pills dispensed, and estimated adherence from the ratio of pills to days since ART initiation (Medication Possession Ratio, adherent if ≥95%) or the period when they stopped receiving medication. RESULTS: Two-thirds (67.7%) were still receiving medication 1 year after initiation; less than half of the cohort (39.1%) were adherent. Younger women, newly diagnosed with HIV, and/or first presenting to antenatal care in their third trimester were more likely to drop from care or be nonadherent 360 days after ART initiation. CONCLUSION: Adherence to ART is suboptimal particularly among young, newly diagnosed, and/or late presenting patients. Interventions that target these groups, as well as provide additional support to all women who are newly diagnosed, may improve Option B+ ART care. More information is needed about the barriers to ART care among late presenters and teenagers.

Does provision of point-of-care CD4 technology and early knowledge of CD4 levels affect early initiation and retention on antiretroviral treatment in HIV-positive pregnant women in the context of Option B+ for PMTCT?

Evidence for Elimination (E4E) is a collaborative project established in 2012 as part of the INSPIRE (INtegrating and Scaling up PMTCT through Implementation REsearch) initiative. E4E is a cluster-randomized trial with 2 arms; Standard of care and "POC Plus" [in which point-of-care (POC) CD4 devices and related counseling support are provided]; aimed at improving retention-in-care of HIV-infected pregnant women and mothers. In November 2013, Zimbabwe adopted Option B+ for HIV-positive pregnant women under which antiretroviral treatment eligibility is no longer based on CD4 count. However, Ministry of Health and Child Care guidelines still require baseline and 6-monthly CD4 testing for treatment monitoring, until viral load testing becomes widely available. Considering the current limited capacity for viral-load testing, the significant investments in CD4 testing already made and the historical reliance on CD4 by health care workers for determining eligibility for antiretroviral treatment, E4E seeks to compare the impact of the provision of POC CD4 technology and early knowledge of CD4 levels on retention-in-care at 12 months, with the current standard of routine, laboratory-based CD4 testing. The study also compares rates of initiation and time-to-initiation between the 2 arms and according to level of maternal CD4 count, the cost of retaining HIV-positive pregnant women in care and the acceptability and feasibility of POC CD4 in the context of Option B+. Outcome measures are derived from routine health systems data. E4E will provide data on POC CD4 testing and retention-in-care associated with Option B+ and serve as an early learning platform to inform implementation of Option B+ in Zimbabwe.