Effect of the Friendship Bench Intervention on Antiretroviral Therapy Outcomes and Mental Health Symptoms in Rural Zimbabwe: A Cluster Randomized Trial.

Importance: Common mental disorders (CMD), which include depression and anxiety, are prevalent among people living with HIV and are associated with suboptimal antiretroviral therapy (ART) adherence. Objective: To assess the effect of a lay health worker-led psychological intervention on ART adherence, virologic suppression, and mental health symptoms. Design, Setting, and Participants: Open-label pragmatic cluster trial with 1:1 block randomization of 16 health facilities in rural Bikita, Zimbabwe. Recruitment occurred from October 2018 to December 2019, and participants were followed up for 12 months, ending in December 2020. Participants were adults aged 18 years and older, who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), received first-line ART for 6 or more months, had no World Health Organization stage 4 disease, no psychosis, were not pregnant, and provided informed consent. Data were analyzed from March 2021 to February 2022. Intervention: The Friendship Bench, consisting of 6 lay health worker-led weekly problem-solving therapy sessions and optional peer-led group support. Main Outcomes and Measures: The primary outcome was mean adherence during 2 to 6 months of follow-up, and the secondary outcomes were mean adherence during 1 to 12 months of follow-up, change in SSQ-14 and Patient Health Questionnaire (PHQ-9) scores (3, 6, 9, and 12 months), and viral load suppression (6 and 12 months). Results: A total of 516 participants were recruited (244 in Friendship Bench and 272 in enhanced standard care facilities); 438 (84.9%) were female and the mean (SD) age was 45.6 (10.9) years. Mean (SD) adherence between 2 to 6 months was 89.9% (18.4%) in the Friendship Bench group and 87.2% (20.1%) in the control group. The intervention had no statistically significant effect on adherence between 2 to 6 months (unadjusted mean difference, 1.93 percentage points; 95% CI, -1.20 to 5.06 percentage points; P = .23), between months 1 to 12 (mean difference 0.79 percentage points; 95% CI, -2.14 to 3.71 percentage points; P = .60), or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (difference, -1.65; 95% CI, -3.07 to -0.24), 6 months (difference, -1.57; 95% CI, -2.98 to -0.15), and 9 months (difference, -1.63; 95% CI, -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (P < .05). There were no differences in the decline in the SSQ-14 scores from baseline to 12 months and in declines in PHQ-9 scores from baseline to 3, 6, 9, and 12 months. Conclusions and Relevance: In this randomized trial of HIV-positive participants with CMD, the Friendship Bench intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and a ceiling effect. Trial Registration: ClinicalTrials.gov Identifier: NCT03704805.

The Evolving Pediatric HIV Epidemic in Rural Southern Zambia: The Beneficial Impact of Advances in Prevention and Treatment at a District Hospital From 2007 to 2019.

BACKGROUND: Remarkable progress has been made in expanding access to services addressing the pediatric HIV epidemic, including programs to prevent mother-to-child transmission, early diagnosis and treatment for children living with HIV. Few long-term data are available from rural sub-Saharan Africa to assess implementation and impact of national guidelines. METHODS: Results from 3 cross-sectional studies and 1 cohort study conducted at Macha Hospital in Southern Province, Zambia from 2007 to 2019 were summarized. For infant diagnosis, maternal antiretroviral treatment, infant test results and turnaround times for results were evaluated by year. For pediatric HIV care, the number and age of children initiating care and treatment, and treatment outcomes within 12 months were evaluated by year. RESULTS: Receipt of maternal combination antiretroviral treatment increased from 51.6% in 2010-2012 to 93.4% in 2019, and the proportion of infants testing positive decreased from 12.4% to 4.0%. Turnaround times for results returning to clinic varied but were shorter when labs consistently used a text messaging system. The proportion of mothers receiving results was higher when a text message intervention was piloted. The number of children living with HIV enrolled into care and the proportion initiating treatment with severe immunosuppression and dying within 12 months decreased over time. CONCLUSIONS: These studies demonstrate the long-term beneficial impact of implementing a strong HIV prevention and treatment program. While expansion and decentralization brought challenges, the program succeeded in decreasing the rate of mother-to-child transmission and ensuring that children living with HIV benefit from access to life-saving treatment.

Effect of the Friendship Bench intervention on antiretroviral therapy outcomes and mental health symptoms in rural Zimbabwe: A cluster randomized trial.

Importance: Common mental disorders (CMD) are prevalent in people living with HIV and associated with suboptimal antiretroviral therapy (ART) adherence. Objective: To assess the effect of a lay health worker-led psychological intervention on adherence to ART, virologic suppression and mental health symptoms. Design: Pragmatic cluster trial with block randomization of health facilities. Treatment assignment was known to participants, providers, evaluators, and data analysts. Recruitment started in October 2018 and the last follow-up visit was done in December 2020. Participants were followed up for 12 months. Setting: Sixteen public health care facilities in Bikita, a rural district in Masvingo Province, about 300 km south of Harare. Participants: Men and non-pregnant women aged 18 years or older who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), had received first-line ART for at least six months, had no WHO clinical stage 4 disease, no psychotic symptoms, and gave informed consent. Intervention: The Friendship Bench, a lay health worker-led intervention consisting of six weekly individual counselling sessions of problem-solving therapy and optional peer-led group support. Main Outcomes and Measures: The primary outcome was Medication Event Monitoring System (MEMS) mean adherence between 2-6 months of follow-up. Secondary outcomes included mean adherence between 1-12 months, change from baseline SSQ-14 and Patient Health Questionnaire (PHQ-9) score at 3, 6, 9, and 12 months and change in viral load suppression (viral load <1000 copies per mL) at months 6 and 12. Results: We recruited 516 participants, 244 in Friendship bench and 272 in standard care facilities. The mean age was 45.6 years (SD 10.9), and most participants were women (84.9%). In the Friendship Bench group, 88.1% of participants attended all six individual counselling sessions. Rates of adherence (>85%) and virologic suppression (>90%) were high in both groups. The intervention had no statistically significant effect on adherence or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (-1.65, 95% CI -3.07 to -0.24), 6 months (-1.57, 95% CI -2.98 to -0.15), and 9 months (-1.63, 95% CI -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (p<0.05). There were no differences in the decline in the SSQ-14 scores from baseline to 12 months and in declines in PHQ-9 scores from baseline to 3, 6, 9, and 12 months. Conclusions and Relevance: The Friendship Bench intervention is a feasible and acceptable approach to closing the treatment gap in mental health care in rural Zimbabwe. The intervention improved CMD symptoms but the intervention effect was smaller than previously shown in an urban setting. The intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and ceiling effect. Trial registration: ClinicalTrials.gov Identifier: NCT03704805. Key points: Question: Does the Friendship Bench intervention improve antiretroviral therapy (ART) adherence, viral suppression and mental health symptoms in people living with HIV in rural Zimbabwe?Findings: In this cluster-randomized trial, participants in the intervention group had a significantly greater decrease in symptoms of common mental disorders than those in the control group, but the intervention showed no significant effect on antiretroviral therapy (ART) adherence or viral suppression.Meaning: The intervention did not affect adherence and viral suppression and the effect of the intervention on mental health symptoms was smaller than previously shown.

High Unreported Mortality in Children and Youth (<25 Years) Living With HIV Who Were Lost to Care From Antiretroviral Therapy Programs in Southern Africa: Results From a Multicountry Tracing Study.

BACKGROUND: Antiretroviral therapy program mortality maybe underestimated if deceased patients are misclassified as lost. METHODS: We used two-stage inverse probability weighting to account for probability of being: sampled for tracing and found by the tracer. RESULTS: Among 680 children and youth aged <25 years on antiretroviral therapy who were lost and traced in Southern Africa between October 2017 and November 2019, estimated mortality was high at 9.1% (62/680). After adjusting for measured covariates and within-site clustering, mortality remained lower for young adults aged 20-24 years compared with infants aged <2 years [adjusted hazard ratio: 0.40 (95% confidence interval: 0.31 to 0.51)]. CONCLUSIONS: Our study confirms high unreported mortality in children and youth who are lost and the need for tracing to assess vital status among those who are lost to accurately report on program mortality.

Availability and experiences of differentiated antiretroviral therapy delivery at HIV care facilities in rural Zimbabwe: a mixed-method study.

INTRODUCTION: Zimbabwe adopted differentiated HIV care policies in 2015 to promote client-centred care and relieve strain on health facilities. We examined the availability, experiences and perceptions of differentiated antiretroviral therapy (ART) delivery in rural Zimbabwe following the policy adoption. METHODS: We undertook a cross-sectional mixed methods study in all the 26 facilities providing HIV care in a rural district in Zimbabwe. We collected quantitative data about ART delivery and visit durations from 31 healthcare providers and a purposive stratified sample of 378 clients obtaining ART either through routine care or differentiated ART delivery models. We performed 26 semi-structured interviews among healthcare providers and seven focus group discussions (FGDs) among clients to elicit their perceptions and experiences of ART delivery. Data were collected in 2019, with one follow-up FGD in 2021. We analysed the transcripts thematically, with inductive coding, to identify emerging themes. RESULTS: Twenty facilities (77%) offered at least one differentiated ART delivery models, including community ART refill groups (CARGs; 13 facilities, 50%), fast-track refill (8, 31%), family refill (6, 23%) or club refill (1, 4%). Thirteen facilities (50%) offered only one model. The median visit duration was 28 minutes (interquartile range [IQR]: 16-62). Participants in fast-track had the shortest visit durations (18 minutes, IQR: 11-24). Confidentiality and disclosure of HIV status, travelling long distances, travel costs and waiting times were the main issues influencing clients' views on differentiated ART delivery. Fast-track refill was perceived as the preferred model of clients for its limited involuntary disclosure and efficiency. In contrast, group- and community-based refill models reduced travel costs but were felt to be associated with involuntary disclosure of HIV status, which could discourage clients. Healthcare providers also experienced an additional workload when offering facility-based group models, such as CARGs. CONCLUSIONS: Differentiated ART delivery models were widely available in this rural setting, but most facilities did not offer a choice of models to address clients' diverse preferences. A minority offered fast-track refills, although this model was often mentioned as desirable. Confidentiality, travel expenses and client waiting times are key elements to consider when planning and rolling out differentiated HIV care.

Tracing People Living With Human Immunodeficiency Virus Who Are Lost to Follow-up at Antiretroviral Therapy Programs in Southern Africa: A Sampling-Based Cohort Study in 6 Countries.

BACKGROUND: Attrition threatens the success of antiretroviral therapy (ART). In this cohort study, we examined outcomes of people living with human immunodeficiency virus (PLHIV) who were lost to follow-up (LTFU) during 2014-2017 at ART programs in Southern Africa. METHODS: We confirmed LTFU (missed appointment for ≥60 or ≥90 days, according to local guidelines) by checking medical records and used a standardized protocol to trace a weighted random sample of PLHIV who were LTFU in 8 ART programs in Lesotho, Malawi, Mozambique, South Africa, Zambia, and Zimbabwe, 2017-2019. We ascertained vital status and identified predictors of mortality using logistic regression, adjusted for sex, age, time on ART, time since LTFU, travel time, and urban or rural setting. RESULTS: Among 3256 PLHIV, 385 (12%) were wrongly categorized as LTFU and 577 (17%) had missing contact details. We traced 2294 PLHIV (71%) by phone calls, home visits, or both: 768 (34% of 2294) were alive and in care, including 385 (17%) silent transfers to another clinic; 528 (23%) were alive without care or unknown care; 252 (11%) had died. Overall, the status of 1323 (41% of 3256) PLHIV remained unknown. Mortality was higher in men than women, higher in children than in young people or adults, and higher in PLHIV who had been on ART <1 year or LTFU ≥1 year and those living farther from the clinic or in rural areas. Results were heterogeneous across sites. CONCLUSIONS: Our study highlights the urgent need for better medical record systems at HIV clinics and rapid tracing of PLHIV who are LTFU.

Regression discontinuity analysis demonstrated varied effect of Treat-All on CD4 testing among Southern African countries.

OBJECTIVE: To determine whether Treat-All policy impacted laboratory testing practices of antiretroviral therapy (ART) programs in Southern Africa. STUDY DESIGN AND SETTING: We used HIV cohort data from Lesotho, Malawi, Mozambique, South Africa, Zambia and Zimbabwe in a regression discontinuity design to estimate changes in pre-ART CD4 testing and viral load monitoring following national Treat-all adoption that occurred during 2016 to 2017. This study included more than 230,000 ART-naïve people living with HIV (PLHIV) aged five years or older who started ART within two years of national Treat-All adoption. RESULTS: We found pre-ART CD4 testing decreased following adoption of Treat-All recommendations in Malawi (-21.4 percentage points (pp), 95% confidence interval, CI: -26.8, -16.0) and in Mozambique (-8.8pp, 95% CI: -14.9, -2.8), but increased in Zambia (+2.7pp, 95% CI: +0.4, +5.1). Treat-All policy had no effect on viral load monitoring, except among females in South Africa (+7.1pp, 95% CI: +1.1, +13.0). CONCLUSION: Treat-All policy expanded ART eligibility, but led to reductions in pre-ART CD4 testing in some countries that may weaken advanced HIV disease management. Continued and expanded support of CD4 and viral load laboratory capacity is needed to further improve treatment successes and allow for uniform evaluation of ART implementation across Southern Africa.

Treatment outcomes among children younger than five years living with HIV in rural Zambia, 2008-2018: a cohort study.

BACKGROUND: HIV testing and treatment guidelines for children in sub-Saharan Africa have evolved over time, such that children are now treated at younger ages. The objective of this study was to describe the treatment experience for immunologic, virologic, and growth outcomes among HIV-infected Zambian children younger than 5 years of age from 2008 to 2018. METHODS: Participants enrolled in a clinical cohort study in Macha, Zambia and initiating antiretroviral treatment before 5 years of age between 2008 and 2015 were included in the analysis and followed up to the end of 2018. Outcomes, including growth, CD4+ T-cell percentage, viral suppression, and mortality, were evaluated among all children using longitudinal and survival analyses. Comparisons by age at treatment initiation (< 1, 1 to < 2, and 2 to < 5 years) were also evaluated. RESULTS: Three hundred eighty-one children initiating treatment before 5 years of age between 2008 and 2015 were included in the analysis. Growth metrics and CD4+ T-cell percentage improved over time after treatment initiation. However, 20% of children remained underweight and 40% of children remained stunted after the first 36 months of treatment. 85% of children had a viral load < 400 copies/mL after 12 months of treatment. However, children < 1 year at treatment initiation were more likely to have a detectable viral load in the first 12 months of treatment and less likely to achieve viral suppression compared to older children. Mortality was highest in the first 12 months of treatment, among underweight children, and among children initiating treatment in 2008-2010 compared to 2011-2015. CONCLUSIONS: Most children initiating antiretroviral treatment from 2008 to 2015 in rural Zambia responded well to treatment. However, many children remained underweight and stunted, and experienced high mortality rates during the first few months of treatment. This supports continued efforts to improve early infant diagnosis, nutritional support, and pediatric drug formulations.

Symptoms of common mental disorders and adherence to antiretroviral therapy among adults living with HIV in rural Zimbabwe: a cross-sectional study.

OBJECTIVES: To examine the proportion of people living with HIV who screen positive for common mental disorders (CMD) and the associations between CMD and self-reported adherence to antiretroviral therapy (ART). SETTING: Sixteen government-funded health facilities in the rural Bikita district of Zimbabwe. DESIGN: Cross-sectional study. PARTICIPANTS: HIV-positive non-pregnant adults, aged 18 years or older, who lived in Bikita district and had received ART for at least 6 months. OUTCOME MEASURES: The primary outcome was the proportion of participants screening positive for CMD defined as a Shona Symptoms Questionnaire score of 9 or greater. Secondary outcomes were the proportion of participants reporting suicidal ideation, perceptual symptoms and suboptimal ART adherence and adjusted prevalence ratios (aPR) for factors associated with CMD, suicidal ideation, perceptual symptoms and suboptimal ART adherence. RESULTS: Out of 3480 adults, 18.8% (95% CI 14.8% to 23.7%) screened positive for CMD, 2.7% (95% CI 1.5% to 4.7%) reported suicidal ideations, and 1.5% (95% CI 0.9% to 2.6%) reported perceptual symptoms. Positive CMD screens were more common in women (aPR 1.67, 95% CI 1.19 to 2.35) than in men and were more common in adults aged 40-49 years (aPR 1.47, 95% CI 1.16 to 1.85) or aged 50-59 years (aPR 1.51, 95% CI 1.05 to 2.17) than in those 60 years or older. Positive CMD screen was associated with suboptimal adherence (aPR 1.53; 95% CI 1.37 to 1.70). CONCLUSIONS: A substantial proportion of people living with HIV in rural Zimbabwe are affected by CMD. There is a need to integrate mental health services and HIV programmes in rural Zimbabwe. TRIAL REGISTRATION NUMBER: NCT03704805.

Trends in CD4 and viral load testing 2005 to 2018: multi-cohort study of people living with HIV in Southern Africa.

INTRODUCTION: The World Health Organization (WHO) recommends a CD4 cell count before starting antiretroviral therapy (ART) to detect advanced HIV disease, and routine viral load (VL) testing following ART initiation to detect treatment failure. Donor support for CD4 testing has declined to prioritize access to VL monitoring. We examined trends in CD4 and VL testing among adults (≥15 years of age) starting ART in Southern Africa. METHODS: We analysed data from 14 HIV treatment programmes in Lesotho, Malawi, Mozambique, South Africa, Zambia and Zimbabwe in 2005 to 2018. We examined the frequency of CD4 and VL testing, the percentage of adults with CD4 or VL tests, and among those having a test, the percentage starting ART with advanced HIV disease (CD4 count <200 cells/mm3 ) or failing to suppress viral replication (>1000 HIV-RNA copies/mL) after ART initiation. We used mixed effect logistic regression to assess time trends adjusted for age and sex. RESULTS: Among 502,456 adults, the percentage with CD4 testing at ART initiation decreased from a high of 78.1% in 2008 to a low of 38.0% in 2017; the probability declined by 14% each year (odds ratio (OR) 0.86; 95% CI 0.86 to 0.86). Frequency of CD4 testing also declined. The percentage starting ART with advanced HIV disease declined from 83.3% in 2005 to 23.5% in 2018; each year the probability declined by 20% (OR 0.80; 95% CI 0.80 to 0.81). VL testing after starting ART varied; 61.0% of adults in South Africa and 10.7% in Malawi were tested, but fewer than 2% were tested in the other four countries. The probability of VL testing after ART start increased only modestly each year (OR 1.06; 95% CI 1.05 to 1.06). The percentage with unsuppressed VL was 8.6%. There was no evidence of a decrease in unsuppressed VL over time (OR 1.00; 95% CI 0.99 to 1.01). CONCLUSIONS: CD4 cell counting declined over time, including testing at the start of ART, despite the fact that many patients still initiated ART with advanced HIV disease. Without CD4 testing and expanded VL testing many patients with advanced HIV disease and treatment failure may go undetected, threatening the effectiveness of ART in sub-Saharan Africa.

Timing of and factors associated with HIV disclosure among perinatally infected children in rural Zambia.

OBJECTIVE: This study was conducted to understand the process of disclosure among HIV-infected children receiving care in rural Zambia. DESIGN: Cross-sectional and longitudinal analyses were conducted within an ongoing clinical cohort study of HIV-infected children receiving care in Macha, Zambia from 2007 to 2016. METHODS: Children receiving HIV care were enrolled into the cohort study and assessed every 3 months. At each study visit, disclosure status was ascertained through questionnaire. Disclosure was categorized as none (child did not know they were chronically ill), partial (child knew they were chronically ill but not of their HIV infection status), or full (child knew they had HIV infection). Barriers to disclosure, and the timing of and factors associated with disclosure, were evaluated among children 5-15 years of age. RESULTS: At study entry, the prevalence of full disclosure increased with age, from 2.1 to 76.2% among children 5-6 and 13-15 years of age, respectively. Reasons provided by caregivers for not disclosing the child's status included they felt the child was too young, they were afraid to, or they did not know how to tell the child. During follow-up, the median age at full disclosure was 9.0 years. Among children with full disclosure, 89.5% first had partial disclosure at a median age of 7.4 years. Factors associated with disclosure included being female, sharing responsibility for taking their own medication, and low weight-for-age z-score. CONCLUSION: Given the complexity of the disclosure process and potential for health benefits, interventions and protocols are needed to support caregivers through the disclosure process.

Temporal Improvements in Long-term Outcome in Care Among HIV-infected Children Enrolled in Public Antiretroviral Treatment Care: An Analysis of Outcomes From 2004 to 2012 in Zimbabwe.

BACKGROUND: Increasing numbers of children are requiring long-term HIV care and antiretroviral treatment (ART) in public ART programs in Africa, but temporal trends and long-term outcomes in care remain poorly understood. METHODS: We analyzed outcomes in a longitudinal cohort of infants (<2 years of age) and children (2-10 years of age) enrolling in a public tertiary ART center in Zimbabwe over an 8-year period (2004-2012). RESULTS: The clinic enrolled 1644 infants and children; the median age at enrollment was 39 months (interquartile range: 14-79), with a median CD4% of 17.0 (interquartile range: 11-24) in infants and 15.0 (9%-23%) in children (P = 0.0007). Among those linked to care, 33.5% dropped out of care within the first 3 months of enrollment. After implementation of revised guidelines in 2009, decentralization of care and increased access to prevention of mother to child transmission services, we observed an increase in infants (48.9%-68.3%; P < 0.0001) and children (48.9%-68.3%; P < 0.0001) remaining in care for more than 3 months. Children enrolled from 2009 were younger, had lower World Health Organization clinical stage, improved baseline CD4 counts than those who enrolled in 2004-2008. Long-term retention in care also improved with decreasing risk of loss from care at 36 months for infants enrolled from 2009 (aHR: 0.57; 95% confidence interval: 0.34-0.95; P = 0.031). ART eligibility at enrollment was a significant predictor of long-term retention in care, while delayed ART initiation after 5 years of age resulted in failure to fully reconstitute CD4 counts to age-appropriate levels despite prolonged ART. CONCLUSIONS: Significant improvements have been made in engaging and retaining children in care in public ART programs in Zimbabwe. Guideline and policy changes that increase access and eligibility will likely to continue to support improvement in pediatric HIV outcomes.

Use of mobile phones and text messaging to decrease the turnaround time for early infant HIV diagnosis and notification in rural Zambia: an observational study.

BACKGROUND: Early infant diagnosis of HIV infection is challenging in rural sub-Saharan Africa as blood samples are sent to central laboratories for HIV DNA testing, leading to delays in diagnosis and treatment initiation. Simple technologies to rapidly deliver results to clinics and notify mothers of test results would decrease many of these delays. The feasibility of using mobile phones to contact mothers was evaluated. In addition, the first two years of implementation of a national short message service (SMS) reporting system to deliver test results from the laboratory to the clinic were evaluated. METHODS: The study was conducted in Macha, Zambia from 2013 to 2015 among mothers of HIV-exposed infants. Mothers were interviewed about mobile phone use and willingness to be contacted directly or through their rural health center. Mothers were contacted according to their preferred method of communication when test results were available. Mothers of positive infants were asked to return to the clinic as soon as possible. Dates of sample collection, delivery of test results to the clinic and notification of mothers were documented in addition to test results. RESULTS: Four hundred nineteen mothers and infants were enrolled. Only 30% of mothers had ever used a mobile phone. 96% of mobile phone owners were reached by study staff and 98% of mothers without mobile phones were contacted through their rural health center. Turnaround times for mothers of positive infants were approximately 2 weeks shorter than for mothers of negative infants. Delivery of test results by the national SMS system improved from 2013 to 2014, with increases in the availability of texted results (38 vs. 91%) and arrival of the texted result prior to the hardcopy report (27 vs. 83%). Texted results arriving at the clinic before the hardcopy were received a median of 19 days earlier. Four discrepancies between texted and hardcopy results were identified out of 340 tests. CONCLUSIONS: Mobile phone and text messaging technology has the potential to improve early infant diagnosis but challenges to widespread implementation need to be addressed, including low mobile phone ownership, use and coverage in rural areas.

Postnatal care utilization and local understandings of contagion among HIV-infected and uninfected women in rural, southern Zambia.

Postnatal care is essential for ensuring the optimal health of newborns and necessary for the prevention of maternal-to-child human immunodeficiency virus (HIV) transmission as well as the early diagnosis and treatment of HIV-infected infants. However, coverage of postnatal care is low in many rural areas of sub-Saharan Africa. We examined women's experiences of accessing formal postnatal care for their HIV-exposed newborns, comparing reports of HIV-infected and uninfected women in an HIV-endemic area of rural southern Zambia. We conducted 24 qualitative in-depth interviews with recently delivered women in a rural region of southern Zambia, including 8 with women who were willing to disclose their HIV infection status and answer additional questions. Data were transcribed, coded and analyzed using thematic analysis techniques. HIV-infected women identified more disincentives and reported more negative experiences accessing postnatal care than HIV-uninfected women. A local notion of contagion holds that healthy infants may become sick with chibele, a fatal, febrile illness, if exposed to another infant who is taking "strong medicine", such as antiretroviral drugs. Thus, HIV-uninfected women expressed objections to sharing clinics with women and infants who were presumed to be under treatment. Additionally, women reported receiving better treatment from staff at HIV clinics compared to general pediatric clinics. Due to these tensions, HIV-infected women were less likely to visit a clinic for newborn care if the clinic or waiting area was a common space used by HIV-uninfected women and their children. When integrating programs for HIV with maternal and child health care, these nuanced tensions between groups of patients must be recognized and resolved.

Delays in Initiation of Antiretroviral Therapy Among HIV-infected Children in Rural Zambia.

BACKGROUND: Although care and treatment are available to many HIV-infected children, barriers remain that delay initiation of antiretroviral therapy (ART). Minimizing these barriers is critical to starting ART at earlier ages. METHODS: Reasons for delay were evaluated among 200 children younger than 15 years of age initiating treatment in an HIV clinic in rural Zambia from 2011 to 2013. RESULTS: The median age of children at ART eligibility was 2.9 years, and 49% were male. After being determined eligible, 60% of children delayed ART initiation for a median of 28 days (interquartile range: 14, 75). Primary reasons for delay included waiting for test results, adherence issues and concurrent treatment for tuberculosis. When reasons for delay were categorized by type, 36% of children had family-related delays, 32% had delays because of clinic logistics, 27% had health-related delays and 6% had other or no identified reasons for delay. The median time between eligibility and ART initiation was shortest for children with delays because of clinic logistics (median: 18 days; interquartile range: 14, 35). Children with family-related delays tended to be older and orphaned, whereas children with delays because of clinic logistics tended to be younger, and children with health-related delays tended to have more advanced disease. In the first year of ART, no association was found between adherence and type of delay. CD4 T-cell percentages and weight-for-age Z scores were lower for children with health-related delays. CONCLUSIONS: Strategies to reduce delays in ART initiation will need to address a diverse set of issues, so children can benefit from earlier treatment.

Skin, thermal and umbilical cord care practices for neonates in southern, rural Zambia: a qualitative study.

BACKGROUND: In Choma District, southern Zambia, the neonatal mortality rate is approximately 40 per 1000 live births and, although the rate is decreasing, many deliveries take place outside of formal facilities. Understanding local practices during the postnatal period is essential for optimizing newborn care programs. METHODS: We conducted 36 in-depth interviews, five focus groups and eight observational sessions with recently-delivered women, traditional birth attendants, and clinic and hospital staff from three sites, focusing on skin, thermal and cord care practices for newborns in the home. RESULTS: Newborns were generally kept warm by application of hats and layers of clothing. While thermal protection is provided for preterm and small newborns, the practice of nighttime bathing with cold water was common. The vernix was considered important for the preterm newborn but dangerous for HIV-exposed infants. Mothers applied various substances to the skin and umbilical cord, with special practices for preterm infants. Applied substances included petroleum jelly, commercial baby lotion, cooking oil and breastmilk. The most common substances applied to the umbilical cord were powders made of roots, burnt gourds or ash. To ward off malevolent spirits, similar powders were reportedly placed directly into dermal incisions, especially in ill children. CONCLUSIONS: Thermal care for newborns is commonly practiced but co-exists with harmful practices. Locally appropriate behavior change interventions should aim to promote chlorhexidine in place of commonly-reported application of harmful substances to the skin and umbilical cord, reduce bathing of newborns at night, and address the immediate bathing of HIV-infected newborns.

High-dose rifapentine with moxifloxacin for pulmonary tuberculosis.

BACKGROUND: Tuberculosis regimens that are shorter and simpler than the current 6-month daily regimen are needed. METHODS: We randomly assigned patients with newly diagnosed, smear-positive, drug-sensitive tuberculosis to one of three regimens: a control regimen that included 2 months of ethambutol, isoniazid, rifampicin, and pyrazinamide administered daily followed by 4 months of daily isoniazid and rifampicin; a 4-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for 2 months followed by moxifloxacin and 900 mg of rifapentine administered twice weekly for 2 months; or a 6-month regimen in which isoniazid was replaced by daily moxifloxacin for 2 months followed by one weekly dose of both moxifloxacin and 1200 mg of rifapentine for 4 months. Sputum specimens were examined on microscopy and after culture at regular intervals. The primary end point was a composite treatment failure and relapse, with noninferiority based on a margin of 6 percentage points and 90% confidence intervals. RESULTS: We enrolled a total of 827 patients from South Africa, Zimbabwe, Botswana, and Zambia; 28% of patients were coinfected with the human immunodefiency virus. In the per-protocol analysis, the proportion of patients with an unfavorable response was 4.9% in the control group, 3.2% in the 6-month group (adjusted difference from control, -1.8 percentage points; 90% confidence interval [CI], -6.1 to 2.4), and 18.2% in the 4-month group (adjusted difference from control, 13.6 percentage points; 90% CI, 8.1 to 19.1). In the modified intention-to-treat analysis these proportions were 14.4% in the control group, 13.7% in the 6-month group (adjusted difference from control, 0.4 percentage points; 90% CI, -4.7 to 5.6), and 26.9% in the 4-month group (adjusted difference from control, 13.1 percentage points; 90% CI, 6.8 to 19.4). CONCLUSIONS: The 6-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen. The 4-month regimen was not noninferior to the control regimen. (Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust; RIFAQUIN Current Controlled Trials number, ISRCTN44153044.).

Association between malaria control and paediatric blood transfusions in rural Zambia: an interrupted time-series analysis.

BACKGROUND: Blood transfusions can reduce mortality among children with severe malarial anaemia, but there is limited evidence quantifying the relationship between paediatric malaria and blood transfusions. This study explores the extent to which the use of paediatric blood transfusions is affected by the number of paediatric malaria visits and admissions. It assesses whether the scale-up of malaria control interventions in a facility catchment area explains the use of paediatric blood transfusions. METHODS: The study was conducted at a referral hospital for 13 rural health centres in rural Zambia. Data were used from facility and patient records covering all paediatric malaria admissions from 2000 to 2008. An interrupted time series analysis using an autoregression-moving-average model was conducted to assess the relationship between paediatric malaria outpatient visits and admissions and the use of paediatric blood transfusions. Further investigation explored whether the use of paediatric blood transfusions over time was consistent with the roll out of malaria control interventions in the hospital catchment area. RESULTS: For each additional paediatric malaria outpatient visit, there were 0.07 additional paediatric blood transfusions (95% CI 0.01-0.13; p < 0.05). For each additional paediatric admission for severe malarial anaemia, there were 1.09 additional paediatric blood transfusions (95% CI 0.95-1.23; p < 0.01). There were 19.1 fewer paediatric blood transfusions per month during the 2004-2006 malaria control period (95% CI 12.1-26.0; p < 0.01), a 50% reduction compared to the preceding period when malaria control was relatively limited. During the 2007-2008 malaria control period, there were 27.5 fewer paediatric blood transfusions per month (95% CI 14.6-40.3; p < 0.01), representing a 72% decline compared to the period with limited malaria control. CONCLUSIONS: Paediatric admissions for severe malarial anaemia largely explain total use of paediatric blood transfusions. The reduction in paediatric blood transfusions is consistent with the timing of the malaria control interventions. Malaria control seems to influence the use of paediatric blood transfusions by reducing the number of paediatric admissions for severe malarial anaemia. Reduced use of blood transfusions could benefit other areas of the health system through greater blood availability, particularly where supply is limited.

Scaling-up access to antiretroviral therapy for children: a cohort study evaluating care and treatment at mobile and hospital-affiliated HIV clinics in rural Zambia.

BACKGROUND: Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia. METHODS: Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility. RESULTS: Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ) and CD4(+) T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4(+) T-cell percentages. CONCLUSIONS: HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas.

Cost-effectiveness of PrEP in HIV/AIDS control in Zambia: a stochastic league approach.

BACKGROUND: Earlier antiretroviral therapy initiation and pre-exposure prophylaxis (PrEP) prevent HIV, although at a substantial cost. We use mathematical modeling to compare the cost-effectiveness and economic affordability of antiretroviral-based prevention strategies in rural Macha, Zambia. METHODS: We compare the epidemiological impact and cost-effectiveness over 40 years of a baseline scenario (treatment initiation at CD4 <350 cells/µL) with treatment initiation at CD4 <500 cells per microliter, and PrEP (prioritized to the most sexually active, or nonprioritized). A strategy is cost effective when the incremental cost-effectiveness ratio (ICER) is <$3480 (<3 times Zambian per capita GDP). Stochastic league tables then predict the optimal intervention per budget level. RESULTS: All scenarios will reduce the prevalence from 6.2% (interquartile range, 5.8%-6.6%) in 2014 to about 1% after 40 years. Compared with the baseline, 16% of infections will be averted with prioritized PrEP plus treatment at CD4 <350, 34% with treatment at CD4 <500, and 59% with nonprioritized PrEP plus treatment at CD4 <500. Only treating at CD4 <500 is cost effective: ICER of $62 ($46-$75). Nonprioritized PrEP plus treating at CD4 <500 is borderline cost effective: ICER of $5861 ($3959-$8483). Initiating treatment at CD4 <500 requires a budget increase from $20 million to $25 million over 40 years, with a 96.7% probability of being the optimal intervention. PrEP should only be considered when the budget exceeds $180 million. CONCLUSIONS: Treatment initiation at CD4 <500 is a cost-effective HIV prevention approach that will require a modest increase in budget. Although adding PrEP will avert more infections, it is not economically feasible, as it requires a 10-fold increase in budget.