Safe inhalation pipe provision (SIPP): protocol for a mixed-method evaluation of an intervention to improve health outcomes and service engagement among people who use crack cocaine in England.

BACKGROUND: Over 180,000 people use crack cocaine in England, yet provision of smoking equipment to support safer crack use is prohibited under UK law. Pipes used for crack cocaine smoking are often homemade and/or in short supply, leading to pipe sharing and injuries from use of unsafe materials. This increases risk of viral infection and respiratory harm among a marginalised underserved population. International evaluations suggest crack pipe supply leads to sustained reductions in pipe sharing and use of homemade equipment; increased health risk awareness; improved service access; reduction in injecting and crack-related health problems. In this paper, we introduce the protocol for the NIHR-funded SIPP (Safe inhalation pipe provision) project and discuss implications for impact. METHODS: The SIPP study will develop, implement and evaluate a crack smoking equipment and training intervention to be distributed through peer networks and specialist drug services in England. Study components comprise: (1) peer-network capacity building and co-production; (2) a pre- and post-intervention survey at intervention and non-equivalent control sites; (3) a mixed-method process evaluation; and (4) an economic evaluation. Participant eligibility criteria are use of crack within the past 28 days, with a survey sample of ~ 740 for each impact evaluation survey point and ~ 40 for qualitative process evaluation interviews. Our primary outcome measure is pipe sharing within the past 28 days, with secondary outcomes pertaining to use of homemade pipes, service engagement, injecting practice and acute health harms. ANTICIPATED IMPACT: SIPP aims to reduce crack use risk practices and associated health harms; including through increasing crack harm reduction awareness among service providers and peers. Implementation has only been possible with local police approvals. Our goal is to generate an evidence base to inform review of the legislation prohibiting crack pipe supply in the UK. This holds potential to transform harm reduction service provision and engagement nationally. CONCLUSION: People who smoke crack cocaine in England currently have little reason to engage with harm reduction and drug services. Little is known about this growing population. This study will provide insight into population characteristics, unmet need and the case for legislative reform. TRIAL REGISTRATION: ISRCTN12541454  https://doi.org/10.1186/ISRCTN12541454.

Targeted combination prevention to support female sex workers in Zimbabwe accessing and adhering to antiretrovirals for treatment and prevention of HIV (SAPPH-IRe): a cluster-randomised trial.

BACKGROUND: Strengthening engagement of female sex workers with health services is needed to eliminate HIV. We assessed the efficacy of a targeted combination intervention for female sex workers in Zimbabwe. METHODS: We did a cluster-randomised trial from 2014 to 2016. Clusters were areas surrounding female sex worker clinics and were enrolled in matched pairs. Sites were randomly assigned (1:1) to receive usual care (free sexual-health services supported by peer educators, including HIV testing on demand, referral for antiretroviral therapy [ART], and health education) or an intervention that supported additional regular HIV testing, on-site initiation of ART, pre-exposure prophylaxis, adherence, and intensified community mobilisation. The primary outcome was the proportion of all female sex workers with HIV viral load 1000 copies per mL or greater, assessed through respondent-driven sampling surveys. We used an adapted cluster-summary approach to estimate risk differences. This trial is registered with Pan African Clinical Trials Registry, number PACTR201312000722390. RESULTS: We randomly assigned 14 clusters to usual care or the intervention (seven in each group). 3612 female sex workers attended clinics in the usual-care clusters and 4619 in the intervention clusters during the study. Half as many were tested (1151 vs 2606) and diagnosed as being HIV positive (546 vs 1052) in the usual-care clusters. The proportion of all female sex workers with viral loads of 1000 copies per mL or greater fell in both study groups (from 421 [30%] of 1363 to 279 [19%] of 1443 in the usual-care group and from 399 [30%] of 1303 to 240 [16%] of 1439 in the intervention group), but with a risk difference at the end of the assessment period of only -2·8% (95% CI -8·1 to 2·5, p=0·23). Among HIV-positive women, the proportions with viral loads less than 1000 copies per mL were 590 (68%) of 869 in the usual-care group and 588 (72%) of 828 in the intervention group at the end of the assessment period, adjusted risk difference of 5·3% (95% CI -4·0 to 14·6, p=0·20). There were no adverse events. INTERPRETATION: Our intervention of a dedicated programme for female sex workers led to high levels of HIV diagnosis and treatment. Further research is needed to optimise programme content and intensity for the broader population. FUNDING: UN Population Fund (through Zimbabwe's Integrated Support Fund funded by UK Department for International Development, Irish Aid, and Swedish International Development Cooperation Agency).

Changes in engagement in HIV prevention and care services among female sex workers during intensified community mobilization in 3 sites in Zimbabwe, 2011 to 2015.

INTRODUCTION: 'Sisters with a Voice', Zimbabwe's nationally scaled comprehensive programme for female sex workers (FSWs), intensified community mobilization activities in three sites to increase protective behaviours and utilization of clinical services. We compare indicators among FSWs at the beginning and after implementation. METHODS: We used mixed methods to collect data at three sites: in-depth interviews (n = 22) in 2015, routine clinical data from 2010 to 2015, and two respondent driven sampling surveys in 2011 and 2015, in which participants completed an interviewer-administered questionnaire and provided a finger prick blood sample for HIV antibody testing. Estimates were weighted using RDS-1 and estimate convergence assessed in both years. We assessed differences in six indicators between 2011 and 2015 using logistic regression adjusted for age, duration in sex work and education. RESULTS: 870 FSWs were recruited from the three sites in 2011 and 915 in 2015. Using logistic regression to adjust for socio-demographic differences, we found higher estimates of the proportion of HIV-positive FSWs and HIV-positive FSWs who knew their status and reported being on ART in Mutare and Victoria Falls in 2015 compared to 2011. Reported condom use with clients did not differ by year; however, condom use with regular partners was higher in 2015 in Mutare and Hwange. Reported HIV testing in the last six months among HIV-negative FSWs was higher in 2015 across sites: for instance, in Victoria Falls it was 13.4% (95% CI 8.7% to 19.9%) in 2011 and 80.8% (95% CI 74.0 to 87.7) in 2015. FSWs described positive perceptions of the Sisters programme, ease of engaging with health services, and improved solidarity among peers. Programme data showed increases in service use by 2015 across all sites. CONCLUSIONS: Improvements in key HIV care engagement indicators were observed among FSWs in two sites and in testing and prevention indicators across the three sites after implementation of an intensified community mobilization intervention. Engagement with services for FSWs is critical for countries to reach 90-90-90 targets.

"Just like fever": a qualitative study on the impact of antiretroviral provision on the normalisation of HIV in rural Tanzania and its implications for prevention.

BACKGROUND: Once effective therapy for a previously untreatable condition is made available, a normalisation of the disease often occurs. As part of a broader initiative to monitor the implementation of the national antiretroviral therapy (ART) programme, this qualitative study investigated the impact of ART availability on perceptions of HIV in a rural ward of North Tanzania and its implications for prevention. METHODS: A mix of qualitative methods was used including semi-structured interviews with 53 ART clinic clients and service providers. Four group activities were conducted with persons living with HIV. Data were analyzed using the qualitative software package NVIVO-7. RESULTS: People on ART often reported feeling increasingly comfortable with their status reflecting a certain "normalization" of the disease. This was attributed to seeing other people affected by HIV, regaining physical health, returning to productive activities and receiving emotional support from health service providers. Overcoming internalized feelings of shame facilitated disclosure of HIV status, helped to sustain treatment, and stimulated VCT uptake. However "blaming" stigma - where people living with HIV were considered responsible for acquiring a "moral disease" - persisted in the community and anticipating it was a key barrier to disclosure and VCT uptake. Attributing HIV symptoms to witchcraft seemed an effective mechanism to transfer "blame" from the family unit to an external force but could lead to treatment interruption. CONCLUSION: As long as an HIV diagnosis continues to have moral connotations, a de-stigmatisation of HIV paralleling that occurring with diseases like cancer is unlikely to occur. Maximizing synergies between HIV treatment and prevention requires an enabling environment for HIV status disclosure, treatment continuation, and safer sexual behaviours. Local leaders should be informed and sensitised and communities mobilised to address the blame-dimension of HIV stigma.

Doubts, denial and divine intervention: understanding delayed attendance and poor retention rates at a HIV treatment programme in rural Tanzania.

Irregular or delayed attendance at HIV treatment clinics among HIV-positive individuals can have negative implications for clinical outcomes and may ultimately undermine the effectiveness of national treatment programmes. This study explores factors influencing attendance at HIV clinic appointments among patients in a rural ward in north-west Tanzania. Forty-two in-depth interviews (IDI) and four focus group discussions were conducted with HIV-infected persons who had been referred to a nearby antiretroviral therapy (ART) clinic, and IDI were undertaken with 11 healthcare workers involved in diagnosis, referral and care of HIV-positive patients. The Health Belief Model was applied to explore the role of health-related beliefs and the perceived barriers and benefits associated with regular clinic attendance. Perceived susceptibility to HIV-related illnesses emerged as an important factor influencing clinic attendance, and was often manifest through expressions of acceptance or denial of HIV status and knowledge of HIV disease progression. Denial of HIV status was often associated with using alternative healers, and could occur prior to, during, or after starting ART. Perceptions of illness severity also influenced HIV clinic attendance, and often evolved in relation to changes in physical symptoms. Barriers to clinic attendance frequently included health systems factors, while physical and social benefits encouraged regular clinic attendance. Self-confidence in being able to sustain clinic attendance was often determined by patients' expectations or experiences of family support. These findings suggest that multi-faceted interventions are required to promote regular HIV clinic attendance, including on-going education, counselling and support in both clinic and community settings. These interventions also need to recognise the evolving needs of patients that accompany changes in physical health, and should address local beliefs around HIV aetiology. Decentralisation of HIV services to rural communities should be considered as a priority to redress the balance between perceived barriers to, and benefits of accessing HIV treatment programmes.

Barriers to accessing antiretroviral therapy in Kisesa, Tanzania: a qualitative study of early rural referrals to the national program.

This community-based, qualitative study conducted in rural Kisesa District, Tanzania, explores perceptions and experiences of barriers to accessing the national antiretroviral programme among self-identified HIV-positive persons. Part of wider operations research around local introduction of HIV therapy, the study involved consultation with villagers and documented early referrals' progress through clinical evaluation and, if eligible, further training and drug procurement. Data collection consisted of 16 participatory group discussions with community members and 18 in-depth interviews with treatment-seekers. Although participants welcomed antiretroviral therapy, they feared that transportation and supplementary food costs, the referral hospital's reputation for being unfriendly and confusing, and difficulties in sustaining long-term treatment would limit accessibility. Fear of stigma framed all concerns, posing challenges for contacting referrals who did not want their status disclosed or expressed reluctance to identify a "treatment buddy" as required by the programme. To mitigate logistical barriers, transportation costs were paid and hospital visits facilitated. Participants reported satisfaction with eligibility testing, finding the process easier than anticipated. Most were willing to join a support group and some changed attitudes toward disclosure. However, both experienced and anticipated discrimination continue to hinder widespread antiretroviral therapy (ART) uptake. While simple measures to reduce perceived barriers improved initial access to treatment and helped overcome anxiety among early referrals, pervasive stigma remains the most formidable barrier. Encouraging successful referrals to share their positive experiences and contribute to nascent community mobililzation could start to address this seemingly intractable problem.