Cell phone counseling improves retention of mothers with HIV infection in care and infant HIV testing in Kisumu, Kenya: A randomized controlled study

Background: We evaluated the effectiveness of a cell phone counseling intervention to promote retention in care and HIV testing of infants among women with HIV accessing prevention of mother-to-child services in Kisumu, Kenya. Methods: Between May 2013 and September 2015, we recruited 404 pregnant women with HIV who were between 14 and 36 weeks of gestation and randomly assigned them to the intervention (n=207) or control arm (n=197). Retention was assessed at delivery and at 6 and 14 weeks postpartum. We also measured uptake of infant HIV testing. The intervention comprised a fixed protocol of counselor-delivered phone calls to provide one-to-one need-based support. The number of calls made varied depending on when participants presented for antenatal care services; the maximum number was 42. The control group received routine care. We evaluated retention at 3 time points using the complementary log-log regression model taking into account factors associated with retention and loss to follow-up time. We calculated the incidence rate for HIV transmission among infants and used binary logistic regression to identify predictors of HIV infection among infants. Results: Participants attended on average 63% of the required number of counseling calls during the study period. Retention was higher in the intervention arm than the control arm at delivery (95.2% vs. 77.7%, respectively); 6 weeks postpartum (93.9% vs. 72.9%, respectively); and 14 weeks postpartum (83.3% vs. 66.5%, respectively) (P<.001). The counseling intervention (hazard ratio [HR]=0.29; 95% confidence interval [CI]=0.12, 0.69) and positive health perceptions (HR=0.99; 95% CI=0.98, 1.00) were associated with lower hazards of being lost to follow-up. HIV testing of infants was higher in the intervention than control arm (93% vs. 68%, respectively; P<.001). In total, 9 of 308 (2.9%) infants tested positive for HIV infection (incidence rate=0.39 infections/100 infant-weeks). Medication Possession Ratio (MPR) >90%, used to assess adherence to ART, was associated with lower odds of a positive HIV test among infants (adjusted odds ratio=0.20; 95% CI=0.04, 0.99). Attendance at antenatal and postnatal care visits was higher among participants in the intervention arm than the control arm. Conclusions: The one-on-one tailored counseling delivered via cell phone was effective in retaining mothers with HIV infection in care and promoting uptake of infant HIV testing and antenatal and postnatal care services. Phone counseling offers a practical approach to reach and retain pregnant women with HIV infection and postpartum mothers in care, but greater emphasis on collection of medications and adherence is required. We conducted a parallel-group, unblinded, randomized controlled study among pregnant women living with HIV who were accessing PMTCT services in Kisumu, Kenya. The primary objective of our study was to determine whether a structured, counselor-delivered, tailored cell phone counseling intervention would increase (1) retention in care until 14 weeks postpartum, and (2) uptake of EID or infant HIV polymerase chain reaction (PCR) testing. As secondary outcomes, we examined HIV transmission among HIV-exposed infants and maternal attendance at ANC and postnatal care (PNC) services. The study was conducted at 14 HIV treatment clinics providing PMTCT services in Kisumu County. High-volume sites were selected in consultation with County AIDS Control officials from a list of clinics providing PMTCT services under the AIDS, Population and Health-Integrated Assistance (APHIA) Plus Program in Kisumu, which is supported by the United States Agency for International Development. All clinics provided similar PMTCT services per the national protocol with regard to provision of antiretroviral (ARV) medications and client follow-up. Between May 2013 and September 2015, pregnant women living with HIV were recruited and randomly assigned to the intervention and control arms using computer-generated random numbers. Participants were followed up to 14 weeks postpartum. We invited pregnant women living with HIV who were between 14 and 36 weeks of gestation, aged ≥16 years, residing in Kisumu and planning to stay there for the next 12 months, willing and able to provide consent, and who had access to a cell phone (owned or shared) to participate in the study. Participants could be ART naïve or experienced (they were currently on ART or had received nevirapine for a previous pregnancy). Clinic nurses informed potential participants about the study, obtained verbal consent, and then introduced them to the study staff for completing consent and recruitment procedures. All study visits were linked to routine maternal and child health services: monthly ANC visits before delivery (the national program recommends a minimum of 4 scheduled comprehensive ANC visits during pregnancy), PNC visit at 6 weeks after delivery (the national program recommends a minimum of 3 visits: the first, between 24 and 48 hours of delivery, the second between 7 and 14 days after delivery, and the third at 6 weeks after delivery), and infant immunization visits at 6, 10, and 14 weeks of age at the clinic (the Expanded Program on Immunization recommends bacille Calmette-Guérin (BCG)/polio/hepatitis B at birth and diphtheria, pertussis, and tetanus (DPT)/polio/hepatitis B/pneumonia at 6, 10, and 14 weeks). Participants completed a baseline interview upon recruitment and an endline interview at 14 weeks postpartum when they visited the center for completing the last of the primary vaccinations for infants. Monthly data were collected when clients visited the clinic for collecting monthly ART medications. Standardized data collection tools, staff training, and regular supervision ensured that study activities were uniform across sites. All newly diagnosed pregnant women living with HIV (ART naïve) and those who became pregnant while on antiretroviral therapy (ART experienced) received routine HIV counseling from ART clinic-based counselors. The counseling included information on the risk of HIV transmission to the infant, the role of ART in PMTCT, the importance of adherence to treatment, disclosure and partner testing, institutional delivery, and infant HIV testing at 6 weeks postpartum. All participants received standard ANC services, which included blood pressure and weight measurements, hemoglobin, syphilis and urine testing, tetanus toxoid immunization, and iron and folic acid supplements. All participants also received standard PNC services, which included mother’s check-up, HIV PCR testing for infants at 6 weeks postpartum, and routine immunization services. All centers had peer community health workers associated with the clinic to support clients and trace those who defaulted or missed visits. In addition to standard care, participants in the intervention arm received one-on-one individualized counseling, delivered via cell phone by 5 trained counselors based at a central study office. The counseling was drawn from the Self-Regulation Theory, which is a system of conscious personal management that involves the process of guiding one’s thoughts, behaviors, and feelings to empower patients to recognize their problems and find solutions.21 The sessions were structured to consist of 2 phone calls during the first week of starting PMTCT services, followed by 1 call/week until the participant delivered (maximum of 26 calls), followed by 2 calls during the first week after delivery and 1 call/week for 14 weeks thereafter (maximum of 16 calls) (Figure 1). The number of calls during the antenatal period varied between participants depending on when they presented for ANC services (between 14 and 36 weeks of gestation). Cell Phone Counseling Protocol The cell phone counseling drew on the Self-Regulation Theory. Training of Counselors: The counselors were trained HIV counselors who had at least 3 years of experience in HIV counseling at various testing centers and had completed at least high school education. The counselors received a 10-day training on the intervention that included theoretical background of the intervention, training on counseling techniques, role play with colleagues and trainers, and practice sessions with volunteers with HIV infection. During the first month, counselors were required to debrief with the program coordinator after each call and receive feedback. Thereafter, the counselors continued with a weekly group discussion on problem cases. Intervention Sessions: After completing recruitment procedures, the research staff put the participants in touch with a study counselor via phone; the participants never met their counselor face-to-face during the entire study period. Participants were required to use their own phones, including a phone shared with a family member or friend. Counselors and patients decided mutually convenient times for the calls. The first session focused on illness representation and problem identification. This was followed by the development and execution of a response plan and evaluation of coping strategies over follow-up sessions. Perceptions or contextual situations that could pose an impediment to ARV adherence or retention in care were identified and participants were encouraged to think about their experiences, interaction with others, sources of information, and cognitive and emotional processes that contributed to their perceptions. Participants were then encouraged to discuss strategies on how to manage their perceptions. Through this process, the counselors introduced replacement perceptions and alternate behaviors. The counselors helped participants address their areas of concern by providing targeted action plans, setting realistic goals, and assessing progress during the next follow-up call. During the early antenatal period (14–32 weeks), counselors focused on the importance of adherence to treatment for their own health and to ensure their baby was born HIV-free. Partner disclosure, partner testing, stigma issues within the family/community, distance to ART centers, and travel constraints were assessed and participants counseled. The focus shifted to emphasize retention in care, institutional delivery, and the need for initiating nevirapine for the baby in the late antenatal period (32–40 weeks) while continuing to emphasize adherence. During the postnatal period (0–15 weeks postpartum), the counselors discussed nevirapine for the infant, infant feeding (exclusive breastfeeding), PCR testing of the infant at 6 weeks, completion of the primary immunization schedule of vaccines, and family planning for the mother while continuing to emphasize the need to continue ART and remain adherent. The Box details the topics covered during the calls. Initial antenatal period (14–32 weeks gestation) Late antenatal period (32–40 weeks gestation) Postnatal period (0–14 weeks postpartum) Participants could make additional need-based calls to the counselor during working hours on weekdays to address concerns or queries. The calls enabled participants to have frequent, personalized, one-on-one contact with a health care professional without visiting the health facility. Data were collected on the frequency and duration of calls made, number of attempts made to reach the client, and reasons for unsuccessful calls. All study participants received a baby gift pack containing soap, baby oil, and disposable napkins when they came for their PNC visit at 6 weeks. Data were collected using structured questionnaires administered by research assistants in Swahili or Luo. Variables were categorized as follows: education as never attended school, received primary education, or attended secondary or university education; marital status as never married, married or cohabiting, or divorced/separated/widowed; living arrangements as lives alone, lives with partner/husband and children, or lives with others. Pregnancy duration at recruitment was categorized as 14–28 weeks or 29–36 weeks; time since HIV-positive status as 1 year or less, 2–4 years, or 5 years or more; and partner/spouse’s HIV status as positive, negative, or unknown. Participants were considered ART naïve if they were diagnosed positive but had never received ART and experienced if they became pregnant while on ART; PMTCT treatment regimens were categorized as Option A or only AZT (zidovudine) for the mother, or Option B or combination of 3 ARVs for the mother; infants received nevirapine under Option A and nevirapine or AZT under Option B.23 Depression was assessed at baseline and endline using the Center for Epidemiologic Studies Depression (CES-D) scale, a 20-item validated scale.24 The scale has a possible range of scores of zero to 60 with higher scores indicating the presence of more symptomology. Depression was categorized as no depression if scores were <16 and depression if scores were ≥16. Perceived stigma was assessed at baseline and endline using a 16-item scale (Cronbach's alpha of adapted scale: 0.81), derived from Berger's HIV stigma scale25 that has been used in other studies in Kenya.26 The scale covered 4 domains: disclosure concerns, negative self-image, concerns about public attitudes, and personalized or experienced stigma. Total scores (range: 16–64) were categorized as low (16–40), moderate (41–52), or high (53–64) stigma. General health perception was assessed using the Health-Related Quality of Life tool used by AIDS Clinical Trials Group studies.27 The tool examines perceptions about general health; resistance to illnesses and health outlook; physical, social, role, and cognitive functioning; and pain. Item scores in each scale are summed to compute raw scale scores that are then transformed to a 0 to 100 scale. Higher scores are indicative of better health functioning. Scores were categorized as above average (61–100) or average or below (≤60). Adherence was assessed using the Medication Possession Ratio (MPR) derived from pharmacy refill information, collected from pharmacy registers, and recorded as a percentage. MPR=Number of days participants had supply of medications/Number of days in the study. For analysis, MPR was dichotomized as ≥90% or <90%. Retention in care was assessed at 3 time points: at delivery, 6 weeks postpartum, and 14 weeks postpartum. Participants who delivered at the health facility where they received PMTCT services, or at another health facility, or for whom there was information of a home delivery and pregnancy outcome were considered retained at delivery. Participants who completed their 6-week PNC visit or had their baby tested for HIV (PCR test) or had the baby immunized at 6 weeks were considered retained at 6 weeks postpartum. Participants who had their baby immunized at 14 weeks were considered retained at 14 weeks postpartum. Participants with stillbirths and infant deaths prior to time points 6 weeks and 14 weeks postpartum were excluded from the analysis. Retention in care was assessed at 3 time points: at delivery, 6 weeks postpartum, and 14 weeks postpartum. Data were collected on HIV testing of the infant. In Kenya, the national program requires infants born to mothers living with HIV to undergo HIV PCR testing at 6 weeks after birth. We collected information on HIV PCR testing undertaken any time between 6 and 14 weeks postpartum from the child health register. Data on attendance at ANC and PNC services, including infant immunization, were collected from the maternal and child health register. Monthly ANC visits coincided with the ARV pick-up from the pharmacy; the number of ANC visits during the study period varied depending on when the participant registered for ANC. Counseling call details, such as number of calls made and duration of each session, were recorded by the counselors and verified from itemized monthly statements. Data were entered using the Census and Survey Processing (CSPro) software program (U.S. Census Bureau and ICF Macro) and analyzed using Intercooled Stata 10.0 (Stata Corporation, College Station, TX). Patients were analyzed within the group to which they were originally assigned. Unpaired Student's t test and Mann-Whitney U tests compared continuous variables with normal and non-normal distributions, respectively, and Pearson's chi-square test was used to compare categorical variables. We compared sociodemographic characteristics, HIV testing and disclosure, pregnancy history, and ART use between intervention and control participants to assess the effectiveness of randomization. We had 2 primary outcomes for this study: retention in care until 14 weeks postpartum and uptake of HIV PCR testing in the infant (EID). For the first outcome, we compared participant retention at 3 discrete time points in the study period: at delivery, 6 weeks postpartum, and 14 weeks postpartum (the endpoint coinciding with the end of the first set of primary immunization for infants). To evaluate retention at 3 time points while taking into account factors associated with retention and time to lost to follow-up (LTFU), we used a complementary log-log regression model, which is an alternative extension of the proportional hazard model for discrete time survival analysis. We calculated the complementary log-log of the hazard function at the 3 defined time points using the following model: where: From the above model, we calculated the hazard ratio of being LTFU for an individual ‘i’ compared to the reference category at time point ‘j’ using following equation: For each predictor variable, the baseline models were controlled for the time variable (the 3 time points), age, education, and marital status. We also examined the interaction effect of the predictor variable with the time variable. In the results, we display the interaction term only when found significant (P<.05). The final model is a multivariate model controlling for age, education, and marital status. This model includes only the variables that were statistically significant in the baseline model. Pearson's chi-square test was used to compare the uptake of EID between the intervention and control arms. The incidence rate for HIV transmission among infants was calculated over the time period from birth to date of HIV PCR test by dividing the number of new infections by the total weeks of exposure. We used binary logistic regression to identify the predictors of HIV infection among infants. We compared the uptake of ANC and PNC services among participants in the 2 groups using Pearson's chi-square test. We also provide relative risk ratios (RRRs) for not attending at least 50% of the required visits (the number varied depending on when the participant registered for ANC), not taking the complete ANC package, not completing 3 PNC visits, not attending the 6-week PNC visit, and not delivering at a health facility in the intervention arm compared with the control arm. The study was approved by the Kenyatta National Hospital, University of Nairobi Ethics and Research Committee and the Institutional Review Board of the Population Council. All participants provided written informed consent.