Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya

Background:Retention of mothers and infants across the prevention of mother-to-child HIV transmission (PMTCT) continuum remains challenging. We assessed the effectiveness of a lay worker administered combination intervention compared with the standard of care (SOC) on mother-infant attrition.Methods:HIV-positive pregnant women starting antenatal care at 10 facilities in western Kenya were randomized using simple randomization to receive individualized health education, retention/adherence support, appointment reminders, and missed visit tracking vs. routine care per guidelines. The primary endpoint was attrition of mother-infant pairs at 6 months postpartum. Attrition was defined as the proportion of mother-infant pairs not retained in the clinic at 6 months postpartum because of mother or infant death or lost to follow-up. Intent-to-treat analysis was used to assess the difference in attrition. This trial is registered with ClinicalTrials.gov; NCT01962220.Results:From September 2013 to June 2014, 361 HIV-positive pregnant women were screened, and 340 were randomized to the intervention (n = 170) or SOC (n = 170). Median age at enrollment was 26 years (interquartile range 22-30); median gestational age was 24 weeks (interquartile range 17-28). Overall attrition of mother-infant pairs was 23.5% at 6 months postpartum. Attrition was significantly lower in the intervention arm compared with SOC (18.8% vs. 28.2%, relative risk (RR) = 0.67, 95% confidence interval: 0.45 to 0.99, P = 0.04). Overall, the proportion of mothers who were retained and virally suppressed (<1000 copies/mL) at 6 months postpartum was 54.4%, with no difference between study arms.Conclusions:Provision of a combination intervention by lay counselors can decrease attrition along the PMTCT cascade in low-resource settings. The study protocol was approved by the Institutional Review Board of Columbia University Medical Center and the Ethical Review Committee of the Kenya Medical Research Institute. The study design was previously described.20 In brief, MIR4Health was an individual-randomized trial comparing the standard of care (SOC) for PMTCT to the study combination intervention among pregnant HIV-positive women and their infants at 10 health facilities (HF) in Kisumu and Siaya Counties, Kenya (Bondo District Hospital (DH), Ahero Sub-DH (SDH), Ambira SDH, Masogo SDH, Ukwala Health Center, Nyakach DH, Madiany DH, Agulu SDH, Siaya DH, and Jaramogi Oginga Odinga Teaching and Referral Hospital). The primary objective was to evaluate the effectiveness of our combination intervention as compared with SOC on attrition among mother–infant pairs at 6 months postpartum. HIV-positive pregnant women were recruited from maternal child health (MCH) clinics at 10 HF supported by ICAP at Columbia University through funding from the President's Emergency Fund for AIDS Relief (PEPFAR) and the Centers for Disease Control and Prevention.21. Women were eligible if they were aged older than 16 years, HIV-positive, able to provide informed consent in English or Luo, and owned or had access to a cell phone. Initially, we included only women who were newly diagnosed HIV-positive at the first antenatal visit. However, to reach study accrual in the expected timeframe, we revised the eligibility criteria to include women who were previously diagnosed with HIV. We excluded women with obstetric conditions requiring referral to another facility for specialized care, and those intending to relocate before 6 months postpartum. Clinic staff referred eligible women to onsite study staff for potential enrollment, and all participants provided written informed consent. Participants were assigned to the intervention or SOC at the enrollment visit using simple randomization. Numbers were generated by the study coordinator, placed in sequentially numbered opaque envelopes, and used in ascending order. Study staff opened envelopes, assigned participants to each study arm after consent had been signed, and enrollment procedures and baseline assessments were completed. Recruitment continued until the target study enrollment for each arm, across all study sites, was met. Participants and study staff were not masked to randomization group. Routine antenatal, delivery, postpartum, and PMTCT care was provided to participants as per Kenyan national guidelines by health facility MCH staff. Antenatal care (ANC) included at least 4 visits during pregnancy depending on gestational age at enrollment; after delivery, mothers and infants received monthly follow-up in the MCH clinic together, for the first 6 months of life. All participants received group health education during ANC visits and had the option to enroll in monthly support group led by facility staff. Option A [antiretroviral treatment (ART) for women with CD4 <350 cells/µL or WHO 3/4, and zidovudine (AZT) after 14 weeks of gestation for women not eligible for ART] was provided at study commencement and changed to option B+ in August 2014, at which time enrollment was complete and follow-up was ongoing; women who received AZT were switched, by clinic staff to ART. As part of routine clinic procedures, women who missed an appointment were to have telephonic follow-up within 1 week, followed by a home visit for those not reached by phone. In addition to SOC services, participants who randomized to the intervention arm were assigned a lay counselor, called a “Mama Mshauri,” at enrollment. The Mama Mshauri provided the following: (1) individualized PMTCT health education using a standardized flip chart during home and clinic visits; (2) retention and adherence support; (3) phone and SMS appointment reminders; (4) and follow-up and tracking for missed clinic visits. Mama Mshauri assisted with expediting service provision, enhancing communication between participants and health providers, assisting participants to identify and problem-solve barriers to retention and adherence, and providing psychosocial support and counseling. All participants attended up to 5 study visits scheduled to coincide with, but conducted separately from, ANC and PMTCT/HIV visits. Study visits were planned to coincide with ANC visit in the first, second, and third trimesters and 6 weeks and 6 months postpartum. At each study visit, research assistants administered questionnaires, covering a range of topics including HIV knowledge, medication beliefs, breastfeeding practices, family planning intention, depression screening, violence, abuse, and stigma. Participants received Kenyan Shilling 400/5 USD per study visit. Blood was drawn for HIV-1 RNA viral load (VL) at the third (32–40 weeks of gestation) and fifth study visits (6 months postpartum); dried blood samples from infants for DNA polymerase chain reaction (PCR) testing were collected at study visits 4 (6 weeks postpartum) for routine early infant diagnosis and 5 (6 months postpartum) for study-specific PCR testing. Study staff contacted all participants who missed a study visit through telephone for rescheduling. Those unable to reschedule were asked to complete a short questionnaire by phone. Women who missed the final study visit were contacted by phone and visited at home to ascertain outcomes. Maternal study follow-up ended if there was a pregnancy loss or infant death. Maternal blood samples for VL were batched and tested at the KEMRI CDC laboratory after study completion using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test. Samples with VL <40 copies/µL were reported as undetectable. For study analysis, we also reported on clients with VL <1000 copies/µL.22 Infant DNA PCR was performed at the KEMRI CDC laboratory, and results were provided to study participants within 21 days of blood draw. Infants were considered HIV infected if DNA PCR was reported as positive. Routinely collected data from ANC, maternity, HIV care, and HIV-exposed infant (HEI) care were abstracted into a customized DHIS2 study database while data from the study questionnaires were entered into a Lime Survey database. To ensure accuracy and completeness, study staff undertook data quality assurance activities to validate data entered and to check for data entry errors. The primary outcome, mother–infant attrition, was defined as the proportion of mother–infant pairs not retained in the clinic at 6 months postpartum because of mother or infant death, or lost to follow-up (LTFU). LTFU was defined as no documented clinic attendance at 6 months postpartum in the 3 months prior or after the 6-month scheduled visit. Maternal clinic attendance was measured through attendance at an ANC or HIV care visit, and infant attendance through attendance at HEI visit, as documented in medical records and registers. We calculated retention among mother–infant pairs at 6 months postpartum to compare outcomes with other reports in the literature. We defined retention as the complement to attrition (percent attrition + percent retention = 100%).23 Women reported to have transferred to another HF were verified through phone call, and these subjects were classified as retained in outcome measures. Secondary outcomes included maternal viral suppression at 6 months postpartum, proportion retained and virally suppressed at 6 months postpartum, and measurements of PMTCT service uptake, exclusive breastfeeding, and infant HIV testing at 6 weeks and 6 months. The study aimed to recruit and randomize 340 HIV-positive pregnant women, 170 in each arm, to detect a 25% relative decrease in attrition with power of 80% at a significance level of 0·05 assuming 40% attrition in the SOC arm (based on historical ICAP data from Kenya). We summarized enrollment characteristics with mean values and proportions and used intent-to-treat (ITT) analysis to compare the risk of attrition between the intervention and SOC arms for mother–infant pairs using Rao–Scott likelihood ratio χ2 test. We report on the combined endpoint of retained and virally suppressed at 6 months postpartum using ITT with women who did not have a VL considered not suppressed. Infant attrition at 6 months postpartum, breastfeeding duration, and infant HIV testing were calculated separately because this was dependent on a live birth. To detect factors that may have modified the effect of the intervention, we also stratified attrition of mother–infant pairs at 6 months by HIV status at enrollment (known HIV-positive or newly identified HIV-positive), maternal age, gestational age, and HIV disclosure to partner at study enrollment. We used Breslow–Day tests for homogeneity to detect statistically significant interactions to examine whether the effect of the intervention varied depending on patient demographics and clinical characteristics. Relative risks and 95% confidence intervals were calculated for the overall comparison and the stratified analyses. Absolute risk differences were also calculated by subtracting the attrition in the intervention arm from the SOC arm. All statistical analyses were performed using SAS 9·4, Cary, NC.