Household- Versus Incentive-Based Contact Investigation for Tuberculosis in Rural South Africa: A Cluster-Randomized Trial.

BACKGROUND: Household contact investigation for people newly diagnosed with tuberculosis (TB) is poorly implemented, particularly in low- and middle-income countries. Conditional cash incentives may improve uptake. METHODS: We conducted a pragmatic, cluster-randomized, crossover trial of 2 TB contact investigation approaches (household-based and incentive-based) in 28 public primary care clinics in South Africa. Each clinic used 1 approach for 18 months, followed by a 6-month washout period, after which the opposite approach was used. Fourteen clinics were randomized to each approach. In the household-based arm, we conducted TB screening and testing of contacts at the household. In the incentive-based arm, both index patients and ≤10 of their close contacts (either within or outside the household) were given small cash incentives for presenting to study clinics for TB screening. The primary outcome was the number of people with incident TB who were diagnosed and started on treatment at study clinics. RESULTS: From July 2016 to January 2020, we randomized 28 clinics to each study arm, and enrolled 782 index TB patients and 1882 contacts in the household-based arm and 780 index patients and 1940 contacts in the incentive-based arm. A total of 1413 individuals started on TB treatment in the household-based arm and 1510 in the incentive-based arm. The adjusted incidence rate ratio of TB treatment initiation in the incentive- versus household-based arms was 1.05 (95% confidence interval: .97-1.13). CONCLUSIONS: Incentive-based contact investigation for TB has similar effectiveness to traditional household-based approaches and may be a viable alternative or complementary approach to household-based investigation.

Mental Health Problems Across the HIV Care Continuum for Adolescents Living with HIV in Sub-Saharan Africa: A Scoping Review.

Mental health problems (e.g., anxiety, depression) are frequently experienced by adolescents living with HIV (ALWH) and can worsen HIV-related outcomes. This scoping review synthesizes the existing research on ALWHs' mental health problems at multiple steps along the HIV care continuum in sub-Saharan Africa. Searching PubMed, CINAHL, EMBASE, and PsycINFO identified 34 peer-reviewed studies that met inclusion criteria. Most studies assessed ALWHs' mental health problems at the "Engaged or Retained in Care" continuum step, are cross-sectional, focus on depression and anxiety, and used measures developed in high-income countries. Studies identify mental health problems among ALWH as prevalent and barriers to care. Significant gaps remain in understanding how mental health problems and their relationships with HIV-related health outcomes shift across the continuum. Additional attention is needed, especially at the HIV testing and viral suppression steps, to generate a more comprehensive understanding of mental health needs and priority timepoints for intervention for ALWH.

From trauma to transmission: exploring the intersection of adversity, substance use, and HIV risk in women's life histories.

BACKGROUND: At increased risk for poor health outcomes, physical and/or sexual violence, and onward transmission of HIV, women who use drugs and are living with HIV (WWUDHIV) are vulnerable and in need of services. Understanding the role of trauma across their life history may offer insights into HIV and drug use prevention and opportunities for intervention. We explored trauma and drug use among WWUDHIV in Dar es Salaam, Tanzania. METHODS: We conducted in-depth interviews with 30 WWUDHIV from January-March 2019. Interviewers used semi-structured interview guides and asked questions about the life history as related to drug use. Interviews were audio recorded, transcribed, translated, coded, and life histories charted. We utilized content analysis. RESULTS: Participants described death of family members as traumatic catalysts for drug use. Sexual partners early in their life history were often the point of introduction to drugs and source of HIV acquisition. Death of partners was present across many life histories and was a traumatic event negatively influencing life trajectories, including start of sex work for survival or to support drug use. Sex work in-turn often led to traumatic events including sexual and/or physical violence. HIV diagnosis for many participants followed the start of drug use, frequently occurred during pregnancy or severe illness and was described by most participants as a trauma. Despite this, particularly during pregnancy, HIV diagnosis was a turning point for some participant's desire to engage in drug use treatment. Traumatic events were often cumulative and regularly described as catalysts for poor mental health that could lead to new or increased drug use for coping. CONCLUSIONS: These findings suggest trauma is common in the life history of WWUDHIV and has negative impacts on drug use and HIV vulnerability. Our life history charting highlights the cumulative and cyclical nature of trauma and drug use in this population. This study allows for better understanding of trauma, drug use, and HIV prevention, which offers opportunities for intervention among a group with limited access to services: during adolescence for orphaned youth, following the death of a child or partner, and when vulnerable women engage with the health system (HIV diagnosis, pregnancy, illness).

Prevalence and predictors of depressive and anxiety symptoms in a sample of women who use drugs in Tanzania: the key role of drug use stigma.

BACKGROUND: Globally, women who use drugs face multiple health vulnerabilities, including poor mental health. Little is known about the mental health burden among women who use drugs in sub-Saharan Africa. This cross-sectional study examined the prevalence and predictors of depressive and anxiety symptoms among a sample of women who use drugs in Dar es Salaam, Tanzania. METHODS: We administered a cross-sectional survey to a non-random sample of 200 women who use drugs in Dar es Salaam between November 2018 and March 2019. We used descriptive statistics to characterize the study sample and fitted separate logistic regression models to assess depressive and anxiety symptoms and their predictors. RESULTS: The percentages of women reporting depressive and anxiety symptoms were 67.5% and 43.7%, respectively. Internalized drug use stigma (AOR = 1.34, 95% CI: 1.03-1.75) and prior attempts to stop heroin use (AOR = 2.99, 95% CI: 1.28-7.00) were associated with depressive symptoms. Enacted drug use stigma from health workers (AOR = 2.02, 95% CI: 1.34-3.04) and anticipated drug use stigma from family (AOR = 1.49, 95% CI: 1.02-2.16) were associated with anxiety symptoms. CONCLUSIONS: Depressive and anxiety symptoms were high among our study sample, with higher reports of symptoms of depression than anxiety. Drug use stigma was a key factor that contributed to elevated symptoms of depression and anxiety.

Post-trial perceptions of a symptom-based TB screening intervention in South Africa: implementation insights and future directions for TB preventive healthcare services.

BACKGROUND: Tuberculosis is a top-10 cause of under-5 mortality, despite policies promoting tuberculosis preventive therapy (TPT). We previously conducted a cluster randomized trial to evaluate the effectiveness of symptom-based versus tuberculin skin-based screening on child TPT uptake. Symptom-based screening did not improve TPT uptake and nearly two-thirds of child contacts were not identified or not linked to care. Here we qualitatively explored healthcare provider perceptions of factors that impacted TPT uptake among child contacts. METHODS: Sixteen in-depth interviews were conducted with key informants including healthcare providers and administrators who participated in the trial in Matlosana, South Africa. The participants' experience with symptom-based screening, study implementation strategies, and ongoing challenges with child contact identification and linkage to care were explored. Interviews were systematically coded and thematic content analysis was conducted. RESULTS: Participants' had mixed opinions about symptom-based screening and high acceptability of the study implementation strategies. A key barrier to optimizing child contact screening and evaluation was the supervision and training of community health workers. CONCLUSIONS: Symptom screening is a simple and effective strategy to evaluate child contacts, but additional pediatric training is needed to provide comfort with decision making. New clinic-based child contact files were highly valued by providers who continued to use them after trial completion. Future interventions to improve child contact management will need to address how to best utilize community health workers in identifying and linking child contacts to care. TRIAL REGISTRATION: The results presented here were from research related to NCT03074799 , retrospectively registered on 9 March 2017.

Perceptions of Community and Clinic-Based Adherence Clubs for Patients Stable on Antiretroviral Treatment: A Mixed Methods Study.

Adherence clubs for patients stable on antiretroviral treatment (ART) offer decongestion of clinics and task-shifting, improved adherence and retention in care. Findings on patient acceptability by club location (in the clinic vs. the community) are limited. This was a mixed-methods study set within a randomized controlled trial of community versus clinic-based adherence clubs for retention in care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa. Participants were surveyed on preferences for adherence club-based care (e.g. location, convenience). We conducted in-depth interviews (IDIs) with 36 participants, and surveyed 568 participants: 49% in community-based clubs and 51% in clinic-based clubs. Participants in both arms favorably rated adherence clubs. Almost all (95%) in clinic-based clubs would recommend them to a friend, while fewer (88% in community-based club participants would do so (p = 0.004). Participants found clubs promoted social support, and were convenient and time-saving, though concerns around stigma and access to other health care were noted within community-based clubs. Adherence clubs are a highly acceptable form of differentiated care for stable ART patients. These data indicate that clinic-based clubs may be preferred above community-based clubs, potentially for reasons of stigma and access to additional health care services.

Contact tracing versus facility-based screening for active TB case finding in rural South Africa: A pragmatic cluster-randomized trial (Kharitode TB).

BACKGROUND: There is a dearth of comparative effectiveness research examining the implementation of different strategies for active tuberculosis (TB) case finding, particularly in rural settings, which represent 60% of the population of sub-Saharan Africa. METHODS AND FINDINGS: We conducted a pragmatic, cluster-randomized comparative effectiveness trial of two TB case finding strategies (facility-based screening and contact tracing) in 56 public primary care clinics in two largely rural districts of Limpopo Province, South Africa. In the facility-based screening arm, sputum Xpert MTB/RIF was performed on all patients presenting (for any reason) with TB symptoms to 28 study clinics, and no contact tracing was performed. In the contact-tracing arm, contacts of patients with active TB were identified (via household tracing in 14 clinics and using small monetary incentives in the other 14 clinics), screened for TB symptoms, and offered Xpert MTB/RIF testing. The primary outcome was the number of newly identified patients with TB started on treatment. The analysis used multivariable Poisson regression adjusted for historical clinic-level TB case volumes and district. The trial was registered with ClinicalTrials.gov (NCT02808507). From July 18, 2017, to January 17, 2019, a total of 3,755 individuals started TB treatment across 56 study clinics in the 18-month period. Clinic characteristics and clinic-level averages of patient characteristics were similar across the two arms: 40/56 (71%) clinics were in a rural location, 2,136/3,655 (58%) patients were male, and 2,243 (61%) were HIV positive. The treatment initiation ratio comparing the yield of TB patients started on treatment in the facility-based arm compared to that from the contact-tracing arm was 1.04 (95% confidence interval [CI] 0.83-1.30, p = 0. 73). In the contact-tracing arm, 1,677 contacts of 788 new TB index patients were screened, yielding 12 new patients with TB. Prespecified subgroup analyses resulted in similar results, with estimated treatment initiation ratios of 0.96 (95% CI 0.64-1.27; p = 0.78) and 1.23 (95% CI 0.87-1.59; p = 0.29) among historically smaller and historically larger clinics, respectively. This ratio was 1.02 (95% CI 0.66-1.37; p = 0.93) and 1.08 (95% CI 0.74-1.42; p = 0.68) in the Vhembe and Waterberg districts, respectively. The estimated treatment initiation ratio was unchanged in sensitivity analyses excluding 24 records whose TB registration numbers could not be verified (1.03, 95% CI 0.82-1.29; p = 0.78) and excluding transfers-in (1.02, 95% CI 0.80-1.29; p = 0.71). Study limitations include the possibility of imbalance on cluster size owing to changes in catchment population over time and the inability to distinguish the independent effects of the two contact investigation strategies. CONCLUSIONS: Contact tracing based on symptom screening and Xpert MTB/RIF testing did not increase the rate of treatment initiation for TB relative to the less resource-intensive approach of facility-based screening in this rural sub-Saharan setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT02808507.

The impact of community- versus clinic-based adherence clubs on loss from care and viral suppression for antiretroviral therapy patients: Findings from a pragmatic randomized controlled trial in South Africa.

BACKGROUND: Adherence clubs, where groups of 25-30 patients who are virally suppressed on antiretroviral therapy (ART) meet for counseling and medication pickup, represent an innovative model to retain patients in care and facilitate task-shifting. This intervention replaces traditional clinical care encounters with a 1-hour group session every 2-3 months, and can be organized at a clinic or a community venue. We performed a pragmatic randomized controlled trial to compare loss from club-based care between community- and clinic-based adherence clubs. METHODS AND FINDINGS: Patients on ART with undetectable viral load at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, were randomized 1:1 to a clinic- or community-based adherence club. Clubs were held every other month. All participants received annual viral load monitoring and medical exam at the clinic. Participants were referred back to clinic-based standard care if they missed a club visit and did not pick up ART medications within 5 days, had 2 consecutive late ART medication pickups, developed a disqualifying (excluding) comorbidity, or had viral rebound. From February 12, 2014, to May 31, 2015, we randomized 775 eligible adults into 12 pairs of clubs-376 (49%) into clinic-based clubs and 399 (51%) into community-based clubs. Characteristics were similar by arm: 65% female, median age 38 years, and median CD4 count 506 cells/mm3. Overall, 47% (95% CI 44%-51%) experienced the primary outcome of loss from club-based care. Among community-based club participants, the cumulative proportion lost from club-based care was 52% (95% CI 47%-57%), compared to 43% (95% CI 38%-48%, p = 0.002) among clinic-based club participants. The risk of loss to club-based care was higher among participants assigned to community-based clubs than among those assigned to clinic-based clubs (adjusted hazard ratio 1.38, 95% CI 1.02-1.87, p = 0.032), after accounting for sex, age, nationality, time on ART, baseline CD4 count, and employment status. Among those who were lost from club-based care (n = 367), the most common reason was missing a club visit and the associated ART medication pickup entirely (54%, 95% CI 49%-59%), and was similar by arm (p = 0.086). Development of an excluding comorbidity occurred in 3% overall of those lost from club-based care, and was not different by arm (p = 0.816); no deaths occurred in either arm during club-based care. Viral rebound occurred in 13% of those lost from community club-based care and 21% of those lost from clinic-based care (p = 0.051). In post hoc secondary analysis, among those referred to standard care, 72% (95% CI 68%-77%) reengaged in clinic-based care within 90 days of their club-based care discontinuation date. The main limitations of the trial are the lack of a comparison group receiving routine clinic-based standard care and the potential limited generalizability due to the single-clinic setting. CONCLUSIONS: These findings demonstrate that overall loss from an adherence club intervention was high in this setting and that, importantly, it was worse in community-based adherence clubs compared to those based at the clinic. We urge caution in assuming that the effectiveness of clinic-based interventions will carry over to community settings, without a better understanding of patient-level factors associated with successful retention in care. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR201602001460157).

Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings.

In-person interactions have traditionally been the gold standard for qualitative data collection. The COVID-19 pandemic required researchers to consider if remote data collection can meet research objectives, while retaining the same level of data quality and participant protections. We use four case studies from the Philippines, Zambia, India and Uganda to assess the challenges and opportunities of remote data collection during COVID-19. We present lessons learned that may inform practice in similar settings, as well as reflections for the field of qualitative inquiry in the post-COVID-19 era. Key challenges and strategies to overcome them included the need for adapted researcher training in the use of technologies and consent procedures, preparation for abbreviated interviews due to connectivity concerns, and the adoption of regular researcher debriefings. Participant outreach to allay suspicions ranged from communicating study information through multiple channels to highlighting associations with local institutions to boost credibility. Interviews were largely successful, and contained a meaningful level of depth, nuance and conviction that allowed teams to meet study objectives. Rapport still benefitted from conventional interviewer skills, including attentiveness and fluency with interview guides. While differently abled populations may encounter different barriers, the included case studies, which varied in geography and aims, all experienced more rapid recruitment and robust enrollment. Reduced in-person travel lowered interview costs and increased participation among groups who may not have otherwise attended. In our view, remote data collection is not a replacement for in-person endeavours, but a highly beneficial complement. It may increase accessibility and equity in participant contributions and lower costs, while maintaining rich data collection in multiple study target populations and settings.

Infant feeding by South African mothers living with HIV: implications for future training of health care workers and the need for consistent counseling.

Background: Since 2010, the World Health Organization recommends lifelong antiretroviral treatment for all women living with HIV, and exclusive breastfeeding for six-months followed by breastfeeding until 24-months for all HIV positive mothers. Nevertheless, many mothers living with HIV do not initiate breastfeeding or stop prematurely, and many countries are still in the process of updating their national infant feeding guidelines to align with World Health Organization recommendations. We sought to understand uptake of breastfeeding and factors that influence decision-making regarding infant feeding in women living with and without HIV who receive ante- and postnatal care at a primary healthcare setting. Methods: Programmatic data on infant feeding intentions and practices among women attending an ante-and postnatal clinic service at a primary care clinic in Johannesburg, South Africa were summarized using descriptive statistics. Qualitative interviews were conducted with 12 healthcare providers, 12 women living with HIV who were breastfeeding and 10 who were formula feeding. Interviews were analyzed using a content analysis approach. Results: Pregnant women living with HIV were less likely to express an intent to breastfeed (71% vs 99%). During the first 6 months postpartum, mothers living with HIV were also less likely to exclusively breastfeed compared to HIV-negative mothers. Mixed messages during infant feeding counselling, social and economic factors, and fear of HIV transmission influenced women's choices to initiate and continue breastfeeding. Conclusions: As infant feeding guidelines for women living with HIV have evolved rapidly in the past 10 years, uniform messages on the low risk of mother-to-child transmission of HIV associated with breastfeeding while on ART and on introduction of complementary foods after 6 months of age are needed.

Acceptability and Preferences among Men and Women for Male Involvement in Antenatal Care.

Introduction. Male involvement in antenatal care (ANC) has been associated with improved prevention of mother-to-child transmission outcomes in Sub-Saharan Africa; yet it remains uncommon. We assess acceptability of male involvement from the male and female perspectives and potential incentives for men to attend ANC. Methods. Adult pregnant women and men attending primary healthcare at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, from October 2013 to January 2014, were recruited using stratified random sampling to ensure equal representation across gender and HIV status. Results. 300/332 individuals (93.8%) offered participation consented. Among the 150 women, 97% had a partner; the majority (92%) preferred partner attendance at ANC, and 14% reported partner attendance during this pregnancy. The 150 men had low knowledge of services rendered at ANC outside of pregnancy monitoring, and few (19%) had previously attended ANC. Blood pressure screening, fatherhood information, and HIV testing were identified by men as incentives for attendance. Women and men expressed high willingness to, respectively, deliver (95%) and respond (97%) to ANC letter invitations. Conclusion. Invitation letters to promote male involvement in ANC are highly acceptable to pregnant women and men. Focusing invitation messages on fatherhood and primary healthcare rather than HIV testing may provide greater motivation for male involvement.