Process evaluation of peer-to-peer delivery of HIV self-testing and sexual health information to support HIV prevention among youth in rural KwaZulu-Natal, South Africa: qualitative analysis.

OBJECTIVE: Peer-to-peer (PTP) HIV self-testing (HIVST) distribution models can increase uptake of HIV testing and potentially create demand for HIV treatment and pre-exposure prophylaxis (PrEP). We describe the acceptability and experiences of young women and men participating in a cluster randomised trial of PTP HIVST distribution and antiretroviral/PrEP promotion in rural KwaZulu-Natal. METHODS: Between March and September 2019, 24 pairs of trained peer navigators were randomised to two approaches to distribute HIVST packs (kits+HIV prevention information): incentivised-peer-networks where peer-age friends distributed packs within their social network for a small incentive, or direct distribution where peer navigators distributed HIVST packs directly. Standard-of-care peer navigators distributed information without HIVST kits. For the process evaluation, we conducted semi-structured interviews with purposively sampled young women (n=30) and men (n=15) aged 18-29 years from all arms. Qualitative data were transcribed, translated, coded manually and thematically analysed using an interpretivist approach. RESULTS: Overall, PTP approaches were acceptable and valued by young people. Participants were comfortable sharing sexual health issues they would not share with adults. Coupled with HIVST, peer (friends) support facilitated HIV testing and solidarity for HIV status disclosure and treatment. However, some young people showed limited interest in other sexual health information provided. Some young people were wary of receiving health information from friends perceived as non-professionals while others avoided sharing personal issues with peer navigators from their community. Referral slips and youth-friendly clinics were facilitators to PrEP uptake. Family disapproval, limited information, daily pills and perceived risks were major barriers to PrEP uptake. CONCLUSION: Both professional (peer navigators) and social network (friends) approaches were acceptable methods to receive HIVST and sexual health information. Doubts about the professionalism of friends and overly exclusive focus on HIVST information materials may in part explain why HIVST kits, without peer navigators support, did not create demand for PrEP.

Improving pathways to care through interventions cocreated with communities: a qualitative investigation of men's barriers to tuberculosis care-seeking in an informal settlement in Blantyre, Malawi.

INTRODUCTION: Men have a higher prevalence of undiagnosed tuberculosis (TB) than women and can spend up to a year longer contributing to ongoing transmission in the community before receiving treatment. Health outcomes are often worse for patients with TB living in informal settlements especially men. This study aimed to understand the barriers preventing men from seeking care for TB and cocreate interventions to address these barriers. METHODS: We used qualitative research methods including in-depth interviews and participatory workshops. Researchers worked with women and men living in Bangwe, an informal settlement in Blantyre, Malawi to develop interventions that reflected their lived realities. The study took place over two phases, in the first phase we undertook interviews with men and women to explore barrier to care seeking, in the second phase we used participatory workshops to cocreate interventions to address barriers and followed up on issues emerging from the workshops with further interviews. In total, 30 interviews were conducted, and 23 participants joined participatory workshops. The team used a thematic analysis to analyse the data. RESULTS: Three interconnected thematic areas shaped men's health TB seeking behaviour: precarious socioeconomic conditions; gendered social norms; and constraints in the health system. Insecurity of day labour with no provision for sick leave; pressure to provide for the household and a gendered desire not to appear weak and a severely under-resourced health system all contributed to men delaying care in this context. Identified interventions included improved patient-provider relations within the health-system, improved workers' health rights and broader social support for households. CONCLUSION: Improving mens' pathways to care requires interventions that consider contextual issues by addressing individual level socioeconomic factors but also broader structural factors of gendered social dynamics and health systems environment.

Evaluation of 6-Month Versus Continuous Isoniazid Preventive Therapy for Mycobacterium tuberculosis in Adults Living With HIV/AIDS in Malawi.

BACKGROUND: To assist the Malawi Ministry of Health to evaluate 2 competing strategies for scale-up of isoniazid preventive therapy (IPT) among HIV-positive adults receiving antiretroviral therapy. SETTING: Malawi. METHODS: We used a multidistrict, compartmental model of the Malawi tuberculosis (TB)/HIV epidemic to compare the anticipated health impacts of 6-month versus continuous IPT programs over a 12-year horizon while respecting a US$10.8 million constraint on drug costs in the first 3 years. RESULTS: The 6-month IPT program could be implemented nationwide, whereas the continuous IPT alternative could be introduced in 14 (of the 27) districts. By the end of year 12, the continuous IPT strategy was predicted to avert more TB cases than the 6-month alternative, although not statistically significant (2368 additional cases averted; 95% projection interval [PI], -1459 to 5023). The 6-month strategy required fewer person-years of IPT to avert a case of TB or death than the continuous strategy. For both programs, the mean reductions in TB incidence among people living with HIV by year 12 were expected to be <10%, and the cumulative numbers of IPT-related hepatotoxicity to exceed the number of all-cause deaths averted in the first 3 years. CONCLUSIONS: With the given budgetary constraint, the nationwide implementation of 6-month IPT would be more efficient and yield comparable health benefits than implementing a continuous IPT program in fewer districts. The anticipated health effects associated with both IPT strategies suggested that a combination of different TB intervention strategies would likely be required to yield a greater impact on TB control in settings such as Malawi, where antiretroviral therapycoverage is relatively high.

Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol.

INTRODUCTION: A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa. METHODS AND ANALYSIS: A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03751826; Pre-results.

HIV self-testing services for female sex workers, Malawi and Zimbabwe.

OBJECTIVE: To present findings from implementation and scale-up of human immunodeficiency virus (HIV) self-testing programmes for female sex workers in Malawi and Zimbabwe, 2013-2018. METHODS: In Zimbabwe, we carried out formative research to assess the acceptability and accuracy of HIV self-testing. During implementation we evaluated sex workers' preferences for, and feasibility of, distribution of test kits before the programme was scaled-up. In Malawi, we conducted a rapid ethnographic assessment to explore the context and needs of female sex workers and resources available, leading to a workshop to define the distribution approach for test kits. Once distribution was implemented, we conducted a process evaluation and established a system for monitoring social harm. FINDINGS: In Zimbabwe, female sex workers were able to accurately self-test. The preference study helped to refine systems for national scale-up through existing services for female sex workers. The qualitative data helped to identify additional distribution strategies and mediate potential social harm to women. In Malawi, peer distribution of test kits was the preferred strategy. We identified some incidents of social harm among peer distributors and female sex workers, as well as supply-side barriers to implementation which hindered uptake of testing. CONCLUSION: Involving female sex workers in planning and ongoing implementation of HIV self-testing is essential, along with strategies to mitigate potential harm. Optimal strategies for distribution and post-test support are context-specific and need to consider existing support for female sex workers and levels of trust and cohesion within their communities.

Poor outcomes in recurrent tuberculosis: More than just drug resistance?

BACKGROUND: Approximately 11% of people reported to have tuberculosis (TB) have previously received treatment. Clinical outcomes are consistently poor on retreatment regimens, however reasons for this are unclear. This study aimed to explore factors which may contribute to unsuccessful outcomes in retreatment TB. METHODS AND FINDINGS: A prospective cohort of consecutive patients starting WHO Category II retreatment regimen was recruited at a central hospital in Malawi. Participants were evaluated at baseline, after completion of the intensive phase at 2-months, and at the end of the 8-month treatment course. Patients were assessed for respiratory co-morbidity; anaemia; renal impairment; diabetes; Anti-retroviral (ART) failure; and drug toxicity. Amongst 158 patients entering TB care at the point of a recurrent episode, only 92 (58%) had a microbiologically confirmed diagnosis. The prevalence of drug resistance was low (9.6%). Of the 158 patients, 131 (83%) were HIV-positive, of whom 96 (73%) were on ART. Of 63 patients on ART >1 year, 24 (38%) had ART failure. Chronic lung disease was found in 88% on CT thorax, including scarring (80%), bronchiectasis (61%), COPD (22%), and destroyed lung (19%). Spirometry revealed restrictive deficit in 60%, and obstructive deficit in 7% of patients. Anaemia and renal impairment were common (34% and 45% respectively). Ototoxicity developed in 32%, and nephrotoxicity in 15%. 40% of patients reported peripheral neuropathy. Liver injury developed in 4%. CONCLUSIONS: If outcomes are to be improved in retreatment TB, there is an urgent need to address the impact of other co-morbid medical conditions including chronic lung disease, HIV and ART failure.

'For a mere cough, men must just chew Conjex, gain strength, and continue working': the provider construction and tuberculosis care-seeking implications in Blantyre, Malawi.

BACKGROUND: Delay by men in seeking healthcare results in their higher mortality while on HIV or tuberculosis (TB) treatment and contributes to ongoing community-level disease transmission before going on treatment. OBJECTIVE: To understand masculinity's role in delay in healthcare seeking for men, with a focus on TB-suggestive symptoms. DESIGN: Data were collected between March 2011 and March 2012 in low-income suburbs in urban Blantyre using focus group discussions with community members (n=8) and health workers (n=2), in-depth interviews with 20 TB patients (female=14) and 20 uninvestigated chronic coughers (female=8), and a 3-day participatory workshop with 27 health stakeholder representatives. The research process drew to a large extent on grounded theory principles in the manner of Strauss and Corbin (1998) and also Charmaz (1995). RESULTS: Role descriptions by both men and women in the study universally assigned men as primary material providers for their immediate family, that is, the ones earning and bringing livelihood and additional material needs. In a context where collectivism was valued, men were also expected to lead the provision of support to wider kin. Successful role enactment was considered key to achieving recognition as an adequate man; at the same time, job scarcity and insecurity, and low earnings gravely impeded men. Pressures to generate continuing income then meant constantly looking for jobs, or working continuously to retain insecure jobs or to raise money through self-employment. All this led men to relegate their health considerations. CONCLUSIONS: Early engagement with formal healthcare is critical to dealing with TB and HIV. However, role constructions as portrayed for men in this study, along with the opportunity costs of acknowledging illness seem, in conditions of vulnerability, important barriers to care-seeking. There is a need to address hidden care-seeking costs and to consider more complex interventions, including reducing precarity, in efforts to improve men's engagement with their health.

Development of sample clean up methods for the analysis of Mycobacterium tuberculosis methyl mycocerosate biomarkers in sputum extracts by gas chromatography-mass spectrometry.

A proof of principle gas chromatography-mass spectrometry method is presented, in combination with clean up assays, aiming to improve the analysis of methyl mycocerosate tuberculosis biomarkers from sputum. Methyl mycocerosates are generated from the transesterification of phthiocerol dimycocerosates (PDIMs), extracted in petroleum ether from sputum of tuberculosis suspect patients. When a high matrix background is present in the sputum extracts, the identification of the chromatographic peaks corresponding to the methyl derivatives of PDIMs analytes may be hindered by the closely eluting methyl ether of cholesterol, usually an abundant matrix constituent frequently present in sputum samples. The purification procedures involving solid phase extraction (SPE) based methods with both commercial Isolute-Florisil cartridges, and purpose designed molecularly imprinted polymeric materials (MIPs), resulted in cleaner chromatograms, while the mycocerosates are still present. The clean-up performed on solutions of PDIMs and cholesterol standards in petroleum ether show that, depending on the solvent mix and on the type of SPE used, the recovery of PDIMs is between 64 and 70%, whilst most of the cholesterol is removed from the system. When applied to petroleum ether extracts from representative sputum samples, the clean-up procedures resulted in recoveries of 36-68% for PDIMs, allowing some superior detection of the target analytes.

Control, struggle, and emergent masculinities: a qualitative study of men's care-seeking determinants for chronic cough and tuberculosis symptoms in Blantyre, Malawi.

BACKGROUND: Men's healthcare-seeking delay results in higher mortality while on HIV or tuberculosis (TB) treatment, and implies contribution to ongoing community-level TB transmission before initiating treatment. We investigated masculinity's role in healthcare-seeking delay for men with TB-suggestive symptoms, with a view to developing potential interventions for men. METHODS: Data were collected during March 2011- March 2012 in three high-density suburbs in urban Blantyre. Ten focus group discussions were carried out of which eight (mixed sex = two; female only = three; male only = three) were with 74 ordinary community members, and two (both mixed sex) were with 20 health workers. Individual interviews were done with 20 TB patients (female =14) and 20 un-investigated chronic coughers (female = eight), and a three-day workshop was held with 27 health stakeholder representatives. RESULTS: An expectation to provide for and lead their families, and to control various aspects of their lives while facing limited employment opportunities and small incomes leaves men feeling inadequate, devoid of control, and anxious about being marginalised as men. Men were fearful about being looked at as less than men, and about their wives engaging in extramarital sex without ability to detect or monitor them. Control was a key defining feature of adequate manhood, and efforts to achieve it also led men into side-lining their health. Articulate and consistent concepts of men's bodily strength or appropriate illness responses were absent from the accounts. CONCLUSIONS: Facilitating men to seek care early is an urgent public health imperative, given the contexts of high HIV/AIDS prevalence but increasingly available treatment, and the role of care-seeking delay in TB transmission. Men's struggles trying to achieve ideal images seem to influence their engagement with their health. Ambiguous views regarding some key masculinity representations and the embrace of less harmful masculinities raise questions about some common assumptions that guide work with men. Apparent 'emergent masculinities' might be a useful platform from which to support the transformation of harmful masculinity. Finally, the complex manifestations of masculinity indicate the need for interventions targeting men in health and TB control to assume supportive, multidimensional and long-term outlooks.

Factors shaping initial decision-making to self-test amongst cohabiting couples in urban Blantyre, Malawi.

In sub-Saharan Africa, most new HIV infections occur in stable relationships, making couples testing an important intervention for HIV prevention. We explored factors shaping the decision-making of cohabiting couples who opted to self-test in Blantyre, Malawi. Thirty-four self-tested participants (17 couples) were interviewed. Motivators for HIV self-testing (HIVST) emerged at three main levels. Individual motivations included perceived benefits of access to treatment, and self-checking of serostatus in the hope of having been cured by prolonged treatment or faith-healing. HIVST was considered convenient, confidential, reassuring and an enabling new way to test with one's partner. Partnership motivations included both positive (mutual encouragement) and negative (suspected infidelity) aspects. For women, long-term health and togetherness were important goals that reinforced motivations for couples testing, whereas men often needed persuasion despite finding HIVST more flexible and less onerous than facility-based testing. Internal conflict prompted some partners to use HIVST as a way of disclosing their previously concealed HIV positive serostatus. Thus, the implementation of community-based HIVST should acknowledge and appropriately respond to decision-making processes within couples, which are shaped by gender roles and relationship dynamics.