Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana.

BACKGROUND: The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and male circumcision is unknown. METHODS: We conducted a pair-matched, community-randomized trial in 30 rural or periurban communities in Botswana from 2013 to 2018. Participants in 15 villages in the intervention group received HIV testing and counseling, linkage to care, ART (started at a higher CD4 count than in standard care), and increased access to male circumcision services. The standard-care group also consisted of 15 villages. Universal ART became available in both groups in mid-2016. We enrolled a random sample of participants from approximately 20% of households in each community and measured the incidence of HIV infection through testing performed approximately once per year. The prespecified primary analysis was a permutation test of HIV incidence ratios. Pair-stratified Cox models were used to calculate 95% confidence intervals. RESULTS: Of 12,610 enrollees (81% of eligible household members), 29% were HIV-positive. Of the 8974 HIV-negative persons (4487 per group), 95% were retested for HIV infection over a median of 29 months. A total of 57 participants in the intervention group and 90 participants in the standard-care group acquired HIV infection (annualized HIV incidence, 0.59% and 0.92%, respectively). The unadjusted HIV incidence ratio in the intervention group as compared with the standard-care group was 0.69 (P = 0.09) by permutation test (95% confidence interval [CI], 0.46 to 0.90 by pair-stratified Cox model). An end-of-trial survey in six communities (three per group) showed a significantly greater increase in the percentage of HIV-positive participants with an HIV-1 RNA level of 400 copies per milliliter or less in the intervention group (18 percentage points, from 70% to 88%) than in the standard-care group (8 percentage points, from 75% to 83%) (relative risk, 1.12; 95% CI, 1.09 to 1.16). The percentage of men who underwent circumcision increased by 10 percentage points in the intervention group and 2 percentage points in the standard-care group (relative risk, 1.26; 95% CI, 1.17 to 1.35). CONCLUSIONS: Expanded HIV testing, linkage to care, and ART coverage were associated with increased population viral suppression. (Funded by the President's Emergency Plan for AIDS Relief and others; Ya Tsie ClinicalTrials.gov number, NCT01965470.).

Methodological Challenges When Studying Distance to Care as an Exposure in Health Research.

Distance to care is a common exposure and proposed instrumental variable in health research, but it is vulnerable to violations of fundamental identifiability conditions for causal inference. We used data collected from the Botswana Birth Outcomes Surveillance study between 2014 and 2016 to outline 4 challenges and potential biases when using distance to care as an exposure and as a proposed instrument: selection bias, unmeasured confounding, lack of sufficiently well-defined interventions, and measurement error. We describe how these issues can arise, and we propose sensitivity analyses for estimating the degree of bias.

Multilevel Factors Affecting Time to Cancer Diagnosis and Care Quality in Botswana.

BACKGROUND: Cancer incidence is increasing in Africa, and the majority of patients are diagnosed with advanced disease, limiting treatment options and survival. We sought to understand care patterns and factors contributing to delayed diagnosis and treatment initiation among patients with cancer in Botswana. PATIENTS AND METHODS: We recruited 20 patients who were enrolled in a prospective cancer cohort in Botswana to a qualitative substudy that explored cancer care pathways and factors affecting cancer care access and quality. We conducted an in-depth interview with each participant between October 2014 and January 2015, using a a structured interview guide with questions about initial cancer symptoms, previous consultations, diagnosis, and care pathways. Medical records were used to confirm dates or treatment details when needed. RESULTS: Individual and interpersonal factors such as cancer awareness and social support facilitated care-seeking behaviors. However, patients experienced multiple delays in diagnosis and treatment because of provider and health system barriers. Health system factors, such as misdiagnosis, understaffed facilities, poor referral communication and scheduling, and inadequate laboratory reporting systems, affected access to and quality of cancer care. CONCLUSION: These findings highlight the need for interventions at the patient, provider, and health system levels to improve cancer care quality and outcomes in Botswana. Results also suggest that widespread cancer education has potential to promote early diagnosis through family and community networks. Identified barriers and facilitators suggest that interventions to improve community education and access to diagnostic technologies could help improve cancer outcomes in this setting. IMPLICATIONS FOR PRACTICE: The majority (54%) of patients with cancer in Botswana present with advanced-stage cancer despite universal access to free health care, limiting the options for treatment and decreasing the likelihood of positive treatment outcomes. To reduce time from symptom onset to cancer treatment initiation, causes of delay in cancer care trajectories must be identified. The narratives of the patients interviewed for this study give insight into psychosocial factors, outlooks on disease, lower-level provider delays, and health system barriers that contribute to substantial delays for patients with cancer in Botswana. Identification of problems and barriers is essential for development of effective interventions to mitigate these factors, in order to improve cancer outcomes in this population.

An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial.

BACKGROUND: Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy (ART) globally initiate treatment prior to delivery, with lack of access to timely CD4 results being a principal barrier. We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART. METHODS: We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone, Botswana. From July 2011-April 2012, 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing. CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed. RESULTS: Three-hundred-sixty-six ART-naïve women were included, 189 registering for antenatal care under Intervention and 177 under Usual Care periods. Of CD4-eligible women, 100 (59.2%) women under Intervention and 79 (50.6%) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation, adjusted odds ratio (aOR, adjusted for time that a clinic initiated Intervention) 0.87 (95% confidence interval [CI]0.47-1.63, P = 0.67). The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days (P<0.001), was appreciated by clinic staff, and was associated with reduced operational cost. However, rates of ART initiation remained low, with 56 (36.4%) women registering under Intervention versus 37 (24.2%) women under Usual Care initiating ART prior to 30 weeks gestation, aOR 1.06 (95%CI 0.53-2.13, P = 0.87). CONCLUSIONS: The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently, and this type of SMS-based results delivery platform may be useful for a variety of tests and settings. However, the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation, as obstacles other than CD4 impeded ART initiation during pregnancy.