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.

Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention.

BACKGROUND: The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. METHODS: This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. RESULTS: Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. CONCLUSIONS: Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220 .

Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

BACKGROUND: Effective retention of HIV-infected mothers and their infants is fraught with multiple challenges, resulting in loss across the continuum of prevention of mother-to-child HIV transmission (PMTCT) care and missed opportunities to offer life-saving HIV prevention and treatment. METHODS: The Mother Infant Retention for Health study is an individual-randomized study evaluating the effectiveness of active patient follow-up compared with standard of care on the combined outcome of attrition of HIV-infected women and their infants at 6 months postpartum. Lay counselors administered the active patient follow-up package of interventions, including individualized health education, use of flip charts during clinic visits, and at home, phone and short message service appointment reminders, active phone and physical tracking of patients immediately after missed clinic visits, and individualized retention and adherence support. RESULTS: Use of study visits to indicate participant progression along the PMTCT cascade highlights the nature of loss among women and infants in PMTCT care because of issues such as pregnancy complications, infant deaths, and transfer out. Delay in implementation of Option B+, unanticipated slow enrollment, a health-care worker strike, rapid HIV test kit shortages, and changes in national PMTCT guidelines necessitated several modifications to the protocol design and implementation to ensure successful completion of the study. CONCLUSIONS: Flexibility when operationalizing an implementation science study is critical in the context of the shifting landscape in a noncontrolled "real-world" setting. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220.

Use of a Comprehensive HIV Care Cascade for Evaluating HIV Program Performance: Findings From 4 Sub-Saharan African Countries.

BACKGROUND: The traditional HIV treatment cascade has been noted to have limitations. A proposed comprehensive HIV care cascade that uses cohort methodology offers additional information as it accounts for all patients. Using data from 4 countries, we compare patient outcomes using both approaches. METHODS: Data from 390,603 HIV-infected adults (>15 years) enrolled at 217 facilities in Kenya, Mozambique, Rwanda, and Tanzania from 2005 to 2011 were included. Outcomes of all patients at 3, 6, and 12 months after enrollment were categorized as optimal, suboptimal, or poor. Optimal outcomes included retention in care, antiretroviral therapy (ART) initiation, and documented transfer. Suboptimal outcomes included retention in care without ART initiation among eligible patients or those without eligibility data. Poor outcomes included loss to follow-up and death. RESULTS: The comprehensive HIV care cascade demonstrated that at 3, 6 and 12 months, 58%, 51%, and 49% of patients had optimal outcomes; 22%, 12%, and 7% had suboptimal outcomes, and 20%, 37% and 44% had poor outcomes. Of all patients enrolled in care, 56% were retained in care at 12 months after enrollment. In comparison, the traditional HIV treatment cascade found 89% of patients enrolled in HIV care were assessed for ART eligibility, of whom 48% were determined to be ART-eligible with 70% initiating ART, and 78% of those initiated on ART retained at 12 months. CONCLUSIONS: The comprehensive HIV care cascade follows outcomes of all patients, including pre-ART patients, who enroll in HIV care over time and uses quality of care parameters for categorizing outcomes. The comprehensive HIV care cascade provides complementary information to that of the traditional HIV treatment cascade and is a valuable tool for monitoring HIV program performance.

Opportunity for prevention of HIV and sexually transmitted infections in Kenyan youth: results of a population-based survey.

BACKGROUND: Data from sentinel serosurveillance are useful to estimate HIV infection in populations but may not be representative of the general population. General population-based surveys attempt to avoid selection bias and are the most appropriate for tracking changes in exposure to risk of HIV infection over time and assessing changes in behavior following prevention campaigns. OBJECTIVES: To provide baseline data for targeted sexually transmitted infection (STI) and HIV infection prevention interventions by studying parameters of sexual behavior and knowledge of HIV infection and STIs, measuring health-seeking behavior related to STIs, and measuring gonorrhea, Chlamydia, syphilis, and HIV-1 prevalences. DESIGN: Population-based survey with stratified sampling by age group from randomly selected households in a suburb of Mombasa, Kenya. METHODS: A standard questionnaire was administered to 1497 consenting adults between the ages of 15 and 49 years who lived in randomly selected households. Urine and blood samples were obtained for the estimation of gonorrhea, chlamydial infection, syphilis, and HIV-1 infection prevalences. RESULTS: Sexual activity in the past 12 months was limited to one partner in all age groups for most sexually active men (68%) and women (88%). More men than women reported two or more partners in the past 12 months (23% vs. 5%, respectively). Almost one half of those persons in the 15- to 19-year-old age group (56% of boys and 48% of girls) were sexually active. Condom use was low with all sexual partners, more so for women than for men. Reported STI symptoms in the past 12 months were high for both men and women. Knowledge of STI symptoms and HIV infection was present but incomplete. Overall HIV seroprevalence was 10.8%, with significantly higher rates among women (13.7%) than among men (8.0%). HIV seroprevalence in the 15- to 19-year-old age group was 3.2%. Female gender, Protestant religion, Catholic religion, and being divorced, separated, and widowed were significantly associated with HIV seroprevalence. Prevalences of gonorrhea, chlamydial infection, and syphilis were 0.9%, 1.5%, and 1.3%, respectively. CONCLUSIONS: This study emphasizes the vulnerability of young adults, in particular young women, to HIV infection and the need for intensive interventions in this group. The low use of condoms, incomplete knowledge of HIV infection and STIs, the high number of reported STIs, and the relatively low HIV-1 seroprevalence among the 15- to 19-year-old group indicate a large need for intensive STI and HIV infection prevention programs, especially for the 15- to 19-year-old age group.