Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial.

BACKGROUND: HIV-TB treatment integration reduces mortality. Operational implementation of integrated services is challenging. This study assessed the impact of quality improvement (QI) for HIV-TB integration on mortality within primary healthcare (PHC) clinics in South Africa. METHODS: An open-label cluster randomized controlled study was conducted between 2016 and 2018 in 40 rural clinics in South Africa. The study statistician randomized PHC nurse-supervisors 1:1 into 16 clusters (eight nurse-supervisors supporting 20 clinics per arm) to receive QI, supported HIV-TB integration intervention or standard of care (control). Nurse supervisors and clinics under their supervision, based in the study health districts were eligible for inclusion in this study. Nurse supervisors were excluded if their clinics were managed by municipal health (different resource allocation), did not offer co-located antiretroviral therapy (ART) and TB services, services were performed by a single nurse, did not receive non-governmental organisation (NGO) support, patient data was not available for > 50% of attendees. The analysis population consists of all patients newly diagnosed with (i) both TB and HIV (ii) HIV only (among patients previously treated for TB or those who never had TB before) and (iii) TB only (among patients already diagnosed with HIV or those who were never diagnosed with HIV) after QI implementation in the intervention arm, or enrolment in the control arm. Mortality rates was assessed 12 months post enrolment, using unpaired t-tests and cox-proportional hazards model. (Clinicaltrials.gov, NCT02654613, registered 01 June 2015, trial closed). FINDINGS: Overall, 21 379 participants were enrolled between December 2016 and December 2018 in intervention and control arm clinics: 1329 and 841 HIV-TB co-infected (10·2%); 10 799 and 6 611 people living with Human Immunodeficiency Virus (HIV)/ acquired immunodeficiency syndrome (AIDS) (PLWHA) only (81·4%); 1 131 and 668 patients with TB only (8·4%), respectively. Average cluster sizes were 1657 (range 170-5782) and 1015 (range 33-2027) in intervention and control arms. By 12 months, 6529 (68·7%) and 4074 (70·4%) were alive and in care, 568 (6·0%) and 321 (5·6%) had completed TB treatment, 1078 (11·3%) and 694 (12·0%) were lost to follow-up, with 245 and 156 deaths occurring in intervention and control arms, respectively. Mortality rates overall [95% confidence interval (CI)] was 4·5 (3·4-5·9) in intervention arm, and 3·8 (2·6-5·4) per 100 person-years in control arm clusters [mortality rate ratio (MRR): 1·19 (95% CI 0·79-1·80)]. Mortality rates among HIV-TB co-infected patients was 10·1 (6·7-15·3) and 9·8 (5·0-18·9) per 100 person-years, [MRR: 1·04 (95% CI 0·51-2·10)], in intervention and control arm clusters, respectively. INTERPRETATION: HIV-TB integration supported by a QI intervention did not reduce mortality in HIV-TB co-infected patients. Demonstrating mortality benefit from health systems process improvements in real-world operational settings remains challenging. Despite the study being potentially underpowered to demonstrate the effect size, integration interventions were implemented using existing facility staff and infrastructure reflecting the real-world context where most patients in similar settings access care, thereby improving generalizability and scalability of study findings. FUNDING: Research reported in this publication was supported by South African Medical Research Council (SAMRC), and UK Government's Newton Fund through United Kingdom Medical Research Council (UKMRC).

A Quality Improvement Intervention to Inform Scale-Up of Integrated HIV-TB Services: Lessons Learned From KwaZulu-Natal, South Africa.

INTRODUCTION: In South Africa, mortality rates among HIV-TB coinfected patients are among the highest in the world. The key to reducing mortality is integrating HIV-TB services, however, a generalizable implementation method and package of tested change ideas to guide the scale-up of integrated HIV-TB services are unavailable. We describe the implementation of a quality improvement (QI) intervention, health systems' weaknesses, change ideas, and lessons learned in improving integrated HIV-TB services. METHODS: Between December 1, 2016, and December 31, 2018, 8 nurse supervisors overseeing 20 primary health care (PHC) clinics formed a learning collaborative to improve a set of HIV-TB process indicators. HIV-TB process indicators comprised: HIV testing services (HTS), TB screening among PHC clinic attendees, isoniazid preventive therapy (IPT) for eligible HIV patients, antiretroviral therapy (ART) for HIV-TB coinfected patients, and viral load (VL) testing at month 12. Routine HIV-TB process data were collected and analyzed. RESULTS: Key change interventions, generated by health care workers, included: patient-flow redesign, daily data quality checks; prior identification of patients eligible for IPT and VL testing. Between baseline and post-QI intervention, IPT initiation rates increased from 15.9% to 76.4% (P=.019), HTS increased from 84.8% to 94.5% (P=.110), TB screening increased from 76.2% to 85.2% (P=.040), and VL testing increased from 61.4% to 74.0% (P=.045). ART initiation decreased from 95.8% to 94.1% (P=.481). DISCUSSION: Although integrating HIV-TB services is standard guidance, existing process gaps to achieve integration can be closed using QI methods. QI interventions can rapidly improve the performance of processes, particularly if baseline performance is low. Improving data quality enhances the success of QI initiatives.

Impact of a provider job aid intervention on injectable contraceptive continuation in South Africa.

Arriving late for scheduled contraceptive reinjections is common in many countries and contributes to discontinuation when providers are unsure how to manage such clients. A clinic-randomized cohort and cross-sectional study with more than 5,000 clients using injectable contraceptives was conducted in the Eastern Cape province of South Africa to test the effectiveness of a provider job aid for managing late-returning clients and promoting continued use of the method. A marginally significant difference in reinjection rates between intervention and control groups was found for those up to two weeks late, and reanalysis excluding one clinic that experienced stockout issues revealed a significant difference. The difference in reinjection rates for those 2-12 weeks late was also found to be significant. The one-reinjection cycle continuation rate for the intervention group was higher than that for the control group, but the difference was not statistically significant. Appropriate management of late-returning clients is critical, and this study illustrates that reinjection rates can be significantly increased with a low-resource provider job aid.

Survey of knowledge, attitudes and practices surrounding the intrauterine device in South Africa.

BACKGROUND: The Copper T intrauterine device (IUD) is a safe, effective, reversible contraceptive that is used widely worldwide but little in South Africa. This study assesses the knowledge, attitudes and practices of potential IUD users and health care providers to inform strategies for expanding IUD use in South Africa. STUDY DESIGN: A descriptive, cross-sectional survey was conducted among 205 clients and 32 health care providers at 12 public sector clinics in two provinces. RESULTS: Twenty-six percent of clients had heard of the IUD; of those, 9% had misconceptions or incorrect information that negatively influenced their opinion of the method. After being given a description of the Copper T IUD, 74% said they would consider using it. Provider knowledge about Copper T IUDs was inaccurate and inadequate. Providers held incorrect beliefs about IUD candidate selection and risks. Almost all providers said that they needed more training and information about the IUD. CONCLUSION: If IUD use is to be expanded in South Africa, potential users will need education about the method and providers will need training on counseling and provision.

Language choice and sexual communication among Xhosa speakers in Cape Town, South Africa: implications for HIV prevention message development.

Communicating about sex is a vital component of human immunodeficiency virus (HIV) prevention and influences how HIV educators convey messages to communities and how couples negotiate safer sex practices. However, sexual communication inevitably confronts culturally based behavioral guidelines and linguistic taboos unique to diverse social contexts. The HIV interventionist needs to identify the appropriate language for sexual communication given the participants and the message. Ethnographic research can help facilitate the exploration of how sex terminology is chosen. A theoretical framework, developed to guide HIV interventionists, suggests that an individual's language choice for sexual communication is influenced by gender roles and power differentials. In-depth interviews, free listing and triadic comparisons were conducted with Xhosa men and women in Cape Town, South Africa, to determine the terms for male genitalia, female genitalia and sexual intercourse that are most appropriate for sexual communication. Results showed that sexual terms express cultural norms and role expectations where men should be powerful and resilient and women should be passive and virginal. For HIV prevention education, non-mother tongue (English and Zulu) terms were recommended as most appropriate because they are descriptive, but allow the speaker to communicate outside the restrictive limits of their mother tongue by reducing emotive cultural connotations.

Community norms for HIV risk behaviors among men in a South African township.

We investigated alcohol-related sexual risk behavior from the perspective of social norms theory. Adults (N = 895, 62% men) residing in a South African township completed street-intercept surveys that assessed risk and protective behaviors (e.g., multiple partners, drinking before sex, meeting sex partners in shebeens, condom use) and corresponding norms. Men consistently overestimated the actual frequency of risky behaviors, as reported by the sample, and underestimated the frequency of condom use. Relative to actual attitudes, men believed that other men were more approving of risk behavior and less approving of condom use. Both behavioral and attitudinal norms predicted the respondents' self-reported risk behavior. These findings indicate that correcting inaccurate norms in HIV-risk reduction efforts is worthwhile.

Knowledge and use of emergency contraception among women in the Western Cape province of South Africa: a cross-sectional study.

BACKGROUND: Emergency contraception (EC) is widely available free of charge at public sector clinics in South Africa. At the same time, rates of teenage and unintended pregnancy in South Africa remain high, and there are few data on knowledge of EC in the general population in South Africa, as in other resource-limited settings. METHODS: We conducted a cross-sectional, interviewer-administered survey among 831 sexually active women at 26 randomly selected public sector clinics in the Western Cape province. RESULTS: Overall, 30% of the women had ever heard of EC when asked directly, after the method was described to them. Only 15% mentioned EC by name or description spontaneously. Knowledge of EC was independently associated with higher education, being married, and living in an urban setting. Four percent of women had ever used EC. DISCUSSION: These data suggest that knowledge of EC in this setting is more common among women of higher socioeconomic status living in urban areas. For EC to play a role in decreasing unintended pregnancy in South Africa, specific interventions are necessary to increase knowledge of the method, where to get it, and the appropriate time interval for its use before the need for EC arises. Future health promotion campaigns should target rural and low socioeconomic status communities.

Timeliness of contraceptive reinjections in South Africa and its relation to unintentional discontinuation.

CONTEXT: Research examining hormonal injectable contraceptive continuation has focused on clients' intentional discontinuation. Little attention, however, has been paid to unintentional discontinuation due to providers' management of clients who would like to continue use but arrive late for their scheduled reinjections. METHODS: A cross-sectional survey of 1,042 continuing injectable clients at 10 public clinics was conducted in South Africa's Western and Eastern Cape provinces. Bivariate logistic regression analyses were used to identify associations between specific variables and the likelihood of receiving a reinjection, among clients who returned to clinics late but within the two-week grace period for reinjection. RESULTS: Of 626 continuing clients in the Western Cape, 29% were up to two weeks late and 25% were 2-12 weeks late for their scheduled reinjection; these proportions among 416 continuing clients in the Eastern Cape were 42% and 16%, respectively. Only 1% of continuing clients in the Western Cape who arrived during the two-week grace period did not receive a reinjection; however, 36% of similar clients in the Eastern Cape did not receive a reinjection. Among late clients in the Eastern Cape who did not receive a reinjection, 64% did not receive any other method. Few variables were significant in bivariate analyses; however, certain characteristics were associated with receiving reinjections among late clients in the Eastern Cape. CONCLUSIONS: It is common for clients to arrive late for reinjections in this setting. Providers should adhere to protocols for the reinjection grace period and have a contraceptive coverage plan for clients arriving past the grace period to reduce clients' risk of unintentional discontinuation and unintended pregnancy.