Novel health system strategies for tuberculin skin testing at primary care clinics: Performance assessment and health economic evaluation.

BACKGROUND: Tuberculin skin test (TST) for guiding initiation of tuberculosis preventive therapy poses major challenges in high tuberculosis burden settings. METHODS: At a primary care clinic in Johannesburg, South Africa, 278 HIV-positive adults self-read their TST by reporting if they felt a bump (any induration) at the TST placement site. TST reading (in mm) was fast-tracked to reduce patient wait time and task-shifted to delegate tasks to lower cadre healthcare workers, and result was compared to TST reading by high cadre research staff. TST reading and placement cost to the health system and patients were estimated. Simulations of health system costs were performed for 5 countries (USA, Germany, Brazil, India, Russia) to evaluate generalizability. RESULTS: Almost all participants (269 of 278, 97%) correctly self-identified the presence or absence of any induration [sensitivity 89% (95% CI 80,95) and specificity 99.5% (95% CI 97,100)]. For detection of a positive TST (induration ≥ 5mm), sensitivity was 90% (95% CI 81,96) and specificity 99% (95% CI 97,100). TST reading agreement between low and high cadre staff was high (kappa 0.97, 95% CI 0.94, 1.00). Total TST cost was 2066 I$ (95% UI 594, 5243) per 100 patients, 87% (95% UI 53, 95) of which were patient costs. Combining fast-track and task-shifting, reduced total costs to 1736 I$ (95% UI 497, 4300) per 100 patients, with 31% (95% UI 15, 42) saving in health system costs. Combining fast-tracking, task-shifting and self-reading, lowered the TST health system costs from 16% (95% UI 8, 26) in Russia to 40% (95% UI 18, 54) in the USA. CONCLUSION: A TST strategy where only patients with any self-read induration are asked to return for fast-tracked TST reading by lower cadre healthcare workers is a promising strategy that could be effective and cost-saving, but real-life cost-effectiveness should be further examined.

Subfertility among HIV-affected couples in a safer conception cohort in South Africa.

BACKGROUND: Subfertility among couples affected by HIV has an impact on the well-being of couples who desire to have children and may prolong HIV exposure. Subfertility in the antiretroviral therapy era and its determinants have not yet been well characterized. OBJECTIVE: The objective of the study was to investigate the burden and determinants of subfertility among HIV-affected couples seeking safer conception services in South Africa. STUDY DESIGN: Nonpregnant women and male partners in HIV seroconcordant or HIV discordant relationships desiring a child were enrolled in the Sakh'umndeni safer conception cohort at Witkoppen Clinic in Johannesburg between July 2013 and April 2017. Clients were followed up prospectively through pregnancy (if they conceived) or until 6 months of attempted conception, after which they were referred for infertility services. Subfertility was defined as not having conceived within 6 months of attempted conception. Robust Poisson regression was used to assess the association between baseline characteristics and subfertility outcomes; inverse probability weighting was used to account for missing data from women lost to safer conception care before 6 months of attempted conception. RESULTS: Among 334 couples enrolled, 65% experienced subfertility (inverse probability weighting weighted, 95% confidence interval, 0.59-0.73), of which 33% were primary subfertility and 67% secondary subfertility. Compared with HIV-negative women, HIV-positive women not on antiretroviral therapy had a 2-fold increased risk of subfertility (weighted and adjusted risk ratio, 2.00; 95% confidence interval, 1.19-3.34). Infertility risk was attenuated in women on antiretroviral therapy but remained elevated, even after ≥2 years on antiretroviral therapy (weighted and adjusted risk ratio, 1.63; 95% confidence interval, 0.98-2.69). Other factors associated with subfertility were female age (weighted and adjusted risk ratio, 1.03, 95% confidence interval, 1.01-1.05 per year), male HIV-positive status (weighted and adjusted risk ratio, 1.31; 95% confidence interval, 1.02-1.68), male smoking (weighted and adjusted risk ratio, 1.29; 95% confidence interval, 1.05-1.60), and trying to conceive for ≥1 year (weighted and adjusted risk ratio, 1.38; 95% confidence interval, 1.13-1.68). CONCLUSION: Two in 3 HIV-affected couples experienced subfertility. HIV-positive women were at increased risk of subfertility, even when on antiretroviral therapy. Both male and female HIV status were associated with subfertility. Subfertility is an underrecognized reproductive health problem in resource-limited settings and may contribute to prolonged HIV exposure and transmission within couples. Low-cost approaches for screening and treating subfertility in this population are needed.

Acceptability and Feasibility of a Mobile Phone-Based Case Management Intervention to Retain Mothers and Infants from an Option B+ Program in Postpartum HIV Care.

The objective of this study was to assess the acceptability and feasibility of a cell phone based case manager intervention targeting HIV-infected pregnant women on highly-active antiretroviral therapy (HAART). Pregnant women ≥36 weeks gestation attending antenatal care and receiving HAART through the Option B+ program at a primary care clinic in South Africa were enrolled into a prospective pilot intervention to receive text messages and telephone calls from a case manager through 6 weeks postpartum. Acceptability and feasibility of the intervention were assessed along with infant HIV testing rates and 10-week and 12-month postpartum maternal retention in care. Retention outcomes were compared to women of similar eligibility receiving care prior to the intervention. Fifty women were enrolled into the pilot from May to July 2013. Most (70%) were HAART-naive at time of conception and started HAART during antenatal care. During the intervention, the case manager sent 482 text messages and completed 202 telephone calls, for a median of 10 text messages and 4 calls/woman. Ninety-six percent completed the postpartum interview and 47/48 (98%) endorsed the utility of the intervention. Engagement in 10-week postpartum maternal HIV care was >90% in the pre-intervention (n = 50) and intervention (n = 50) periods; by 12-months retention fell to 72% and was the same across periods. More infants received HIV-testing by 10-weeks in the intervention period as compared to pre-intervention (90.0 vs. 63.3%, p < 0.01). Maternal support through a cell phone based case manager approach was highly acceptable among South African HIV infected women on HAART and feasible, warranting further assessment of effectiveness.

High uptake of systematic HIV counseling and testing and TB symptom screening at a primary care clinic in South Africa.

BACKGROUND: Timely diagnosis and treatment of tuberculosis (TB) and HIV is important to reduce morbidity and mortality, and break the cycle of ongoing transmission. METHODS: We performed an implementation research study to develop a model for systematic TB symptom screening and HIV counseling and testing (HCT) for all adult clients at a primary care clinic and prospectively evaluate the 6-month coverage and yield, and 18-month sustainability at a primary care clinic in Johannesburg, South Africa. RESULTS: During the first 6 months, 26,515 visits occurred among 12,078 adults. The proportion of adults aware of their HIV status was 43.7% at the start of the first visit, increased to 84.6% at the end of the first visit, and to 90% at end of any visit during the first 6 months. During these 6 months, 1042 clients were newly diagnosed with HIV. HIV prevalence was 22.9% among those newly tested, and 58.9% among all adult clinic clients. High coverage of systematic HCT was sustained across all 18 months. Coverage of systematic HIV-stratified TB symptom screening during first 6-months was also high (89.6%) but only 35.0% of those symptomatic were screened by sputum. During these 6-months, 90 clients had a positive Xpert MTB/RIF assay, corresponding to a TB prevalence of 0.4% among all 23,534 clients TB symptom-screened and 2.8% among the 3,284 clients with a positive TB symptom screen. The initial high coverage of TB symptom screening was not sustained, with coverage of TB symptom screening dropping after the first six months to 70% and assessment by sputum dropping to 15%. CONCLUSION: Routine, systematic HCT and HIV-stratified TB symptom screening is feasible at primary care level. Systematic HCT doubled the proportion of clients with known HIV status. While HCT was sustainable, coverage of systematic TB screening dropped significantly after the first 6 months of implementation.

Impact of systematic HIV testing on case finding and retention in care at a primary care clinic in South Africa.

OBJECTIVE: Systematic, opt-out HIV counselling and testing (HCT) may diagnose individuals at lower levels of immunodeficiency but may impact loss to follow-up (LTFU) if healthier people are less motivated to engage and remain in HIV care. We explored LTFU and patient clinical outcomes under two different HIV testing strategies. METHODS: We compared patient characteristics and retention in care between adults newly diagnosed with HIV by either voluntary counselling and testing (VCT) plus targeted provider-initiated counselling and testing (PITC) or systematic HCT at a primary care clinic in Johannesburg, South Africa. RESULTS: One thousand one hundred and forty-four adults were newly diagnosed by VCT/PITC and 1124 by systematic HCT. Two-thirds of diagnoses were in women. Median CD4 count at HIV diagnosis (251 vs. 264 cells/µl, P = 0.19) and proportion of individuals eligible for antiretroviral therapy (ART) (67.2% vs. 66.7%, P = 0.80) did not differ by HCT strategy. Within 1 year of HIV diagnosis, half were LTFU: 50.5% under VCT/PITC and 49.6% under systematic HCT (P = 0.64). The overall hazard of LTFU was not affected by testing policy (aHR 0.98, 95%CI: 0.87-1.10). Independent of HCT strategy, males, younger adults and those ineligible for ART were at higher risk of LTFU. CONCLUSIONS: Implementation of systematic HCT did not increase baseline CD4 count. Overall retention in the first year after HIV diagnosis was low (37.9%), especially among those ineligible for ART, but did not differ by testing strategy. Expansion of HIV testing should coincide with effective strategies to increase retention in care, especially among those not yet eligible for ART at initial diagnosis.

Time to treatment and patient outcomes among TB suspects screened by a single point-of-care xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa.

INTRODUCTION: In December 2010, the World Health Organization recommended a single Xpert MTB/RIF assay as the initial diagnostic in people suspected of HIV-associated or drug resistant tuberculosis. Few data are available on the impact of this recommendation on patient outcomes. We describe the diagnostic follow-up, clinical characteristics and outcomes of a cohort of tuberculosis suspects screened using a single point-of-care Xpert. METHODS: Consecutive tuberculosis suspects at a primary care clinic in Johannesburg, South Africa were assessed for tuberculosis using point-of-care Xpert. Sputum smear microscopy and liquid culture were performed as reference standards. Xpert-negatives were evaluated clinically, and further assessed at the discretion of clinicians. Participants were followed for six months. RESULTS: From July-September 2011, 641 tuberculosis suspects were enrolled, of whom 69% were HIV-infected. Eight percent were positive by a single Xpert. Among 116 individuals diagnosed with TB, 66 (57%) were Xpert negative, of which 44 (67%) were empirical or radiological diagnoses and 22 (33%) were Xpert negative/culture-positive. The median time to tuberculosis treatment was 0 days (IQR: 0-0) for Xpert positives, 14 days (IQR: 5-35) for those diagnosed empirically, 14 days (IQR: 7-29) for radiological diagnoses, and 144 days (IQR: 28-180) for culture positives. Xpert negative tuberculosis cases were clinically similar to Xpert positives, including HIV status and CD4 count, and had similar treatment outcomes including mortality and time to antiretroviral treatment initiation. CONCLUSIONS: In a high HIV-burden setting, a single Xpert identified less than half of those started on tuberculosis treatment, highlighting the complexity of TB diagnosis even in the Xpert era. Xpert at point-of-care resulted in same day treatment initiation in Xpert-positives, but had no impact on tuberculosis treatment outcomes or mortality.