Differentiated Prevention and Care to Support the Virtual Elimination of risk of acquisition and or transmission of HIV Among Sex Workers in Southern Africa – AMETHIST (Adapted Microplanning: Eliminating Transmissible HIV In Sex Transactions)
Funding Source: Wellcome Trust
Funding Period: October 2019-December 2024
The overall goal for this study is to develop and evaluate a micro-planning intervention for Africa, considering the heterogeneity of FSWs and their experiences and deepen the understanding of how to optimise the implementation and determine population impact and cost-effectiveness.
The study is being conducted at the 57 static and outreach sites where the National Sex Work Program is being implemented. Findings will help to inform health care policy in Africa. The study has several sub-studies that will be conducted at different time points over the course of five years:
- The study will commence with an expanded analysis of program data. Since its inception in 2009, the Sisters with a Voice Program has been collecting program data from program beneficiaries for different purposes, from different locations and at different time periods. We will conduct an analysis of this program data and findings will be used to refine the intervention.
- A series of quantitative and qualitative sub-studies will be conducted to explore and understand how sex workers transition in and out of sex work and what are the implications of these transitions on their engagement into prevention, treatment, care and support services.
- We are evaluating the use of microplanning as an HIV prevention and care differentiated community support model for FSWs in Zimbabwe in an impact evaluation. The impact evaluation is nested within the Sisters with a Voice Program. In this study 22 outreach sites were randomised to either receive the enhanced microplanning intervention and self-help groups or standard care. Microplanning activities commenced in June 2019.
- We will refine an existing individual based micro simulation model to predict the impact and cost-effectiveness of intervention to increase engagement with treatment and care services
- In order to understand whether findings obtained from the Zimbabwean context can be translated into other African settings, we will describe the patterns and life course of sex work in Malawi and rural KwaZulu-Natal (KZN), South Africa, where the contexts of sex work are different from Zimbabwe.
Engaging Young People in the Development of Digital Mental Health Innovation in Africa
Funding Source: UKRI
Funding Period: May 2020 – Apr 2021
The chief aim is to develop a robust framework for responsible and relevant digital mental health interventions for young people in African countries. The transdisciplinary network will have a group of young people at its core, who will co-create all its work and outputs.
Project activities will include:
- Intensive training and capacity-building opportunities for early career researchers (ECR) and young people (e.g. workshops; visiting scholar programmes);
- Meetings and workshops to facilitate the transfer of knowledge among stakeholders;
- Literature reviews to critically assess and synthesize existing work, identify gaps, and formulate research questions
- Community engagement to inform empirical questions
- Young people to co-create a sustainable engagement strategy to involve-ing other young people, with a focus on representation from vulnerable groups, such as Lesbian, Gay, Bisexual, Transgender, Queer or Questioning, and Intersex.(LGBTQ+); sexual violence survivors; those living with HIV/AIDS
Young people will be at the core of the Network, integrated with expert groups of researchers in ethics and social sciences; service providers (app developers, mental health practitioners and researchers); religious congregations; policy and governance decision-makers. This will ensure that the network outputs reflect the needs of young people and that the framework is scalable and sustainable as it is co-produced with young people, researchers, service providers, and policy makers.
Pilot study to assess the feasibility and utility of recent infection testing for HIV within an outreach programme for female sex workers in Zimbabwe
Funding Source: Bill and Melinda Gates Foundation
Funding Period: October 2019 to December 2022
The overall goal of this study is to distinguish between recent and long-standing HIV infection among female sex in Zimbabwe. The first phase of the pilot study commenced in June 2018 and was completed in 2019. An analysis of DBS samples collected from participants from previous studies was conducted. In addition samples were collected prospectively from newly diagnosed HIV positive sex workers at six National Sex Work static sites: Harare, Bulawayo, Gweru, Karoi, Masvingo and Mutare. A total of 103 (4.12%) from 2499 analysed DBS samples were recently infected . Factors associated with recent infection after adjustment were age at start of sex work (p<0.001), STI symptoms in past year . Of the 366 newly diagnosed HIV positive FSW, 33
(10.5%) had been recently infected. We received additional funding to recruit an additional 600 women in 2020 and we are anticipating to repeat recency testing annually until 2022. The study will now be extended from the initial 6 to all the 57 static and outreach sites and will include male and transgender key populations in addition to female sex workers.
Improving access to HIV services for sex workers in Zimbabwe: field study and mathematical modeling
Funding source: AIDSfonds through Dept. of Public Health, Erasmus Medical Center
Rotterdam, The Netherlands
Funding period: December 2017 to January 2022
The main objective of this study is to determine the impact of improved access to services for key populations in Zimbabwe including female , male and transgender sex workers through mathematical modeling and secondary data analyses. The project, a collaborative research initiative between CeSHHAR and the Department of Public Health, Erasmus Medical Center Rotterdam, The Netherlands is analyzing routine data collected for the National Sex work Program on female sex workers, male and transgender sex workers.
To date, a total of 100 male and transgender sex workers have been enrolled in the study.
Progress towards developing a mathematical model to allow for incorporating male and
transgender sex workers as part of the HIV transmission dynamics has been made.
Impact Evaluation of DREAMS in Zimbabwe –focusing on impact in young women who sell sex
Funding Source: Bill and Melinda Gates Foundation subcontracted by London School of Hygiene and Tropical Medicine
Funding Period: January 2016 to December 2019
DREAMS is a combined package of interventions that aims to reduce the risk of HIV among the most vulnerable adolescent girls and young women (AGYW). The package combines strategies to reduce the biological risk of infection, through the provision of condoms, STI treatment and oral pre-exposure prophylaxis (PrEP) to AGYW at highest risk of infection. DREAMS encourages AGYW to use and access these services through the provision of socioeconomic empowerment interventions, including transport vouchers and cash transfers, with strategies to change community-level norms around violence against AGYW and access to school, social and financial assets. This impact evaluation aims to estimate the impact of the DREAMS combined package (which includes an offer of PrEP) on the risk of HIV infection among AGYW at highest risk of HIV in Zimbabwe. The overall aim of this impact evaluation is to estimate the impact of the DREAMS combination package of HIV prevention interventions, which includes an offer of PrEP, on HIV incidence among YWSS in Zimbabwe, including young women who engage in transactional sex and therefore at high risk of entry into sex work.
SECONDARY ANALYSES OF ANONYMISED PROGRAMME DATA COLLECTED THROUGH THE SISTERS WITH A VOICE PROGRAMME BY CESHHAR ZIMBABWE ON BEHALF OF MOHCC AND NAC.
Principal investigator and LSTM lead: Professor Frances Cowan
Co- Principal Investigator and Zimbabwe Lead: Dr Fortunate Machingura
Period of implementation: March 2020 to September 2025
Over the last decade CeSHHAR has generated a wealth of data from programme beneficiaries and research participants collected for different purposes, at different locations, over different time periods and in different populations. We are undertaking an expanded analysis of these data to refine design of the interventions, and structure and parameterise the mathematical model.
Our secondary analyses of data explore trends in programme data, determine programme coverage, gaps in engagement with prevention and care and explore how the characteristics of programme beneficiaries compare with sex workers recruited using survey sampling methods designed to recruit representative populations.
These data are non-research, health record data that are being anonymised and de-linked for analysis. Our data are collected by the programme from sex workers at each encounter with the programme for the purposes of supporting programme delivery and individual clinical care. The data are routinely collected using encrypted, password-protected, tablet computers and transferred to an electronic database near real-time. Each sex worker is allocated a unique identifier at their first contact with the programme (alphanumeric code) which is stored securely in a separate password protected and encrypted link log and separately from any clinical or other programme data.
CLUSTER RANDOMIZED TRIAL OF MICROPLANNING, AN HIV PREVENTION AND CARE DIFFERENTIATED COMMUNITY SUPPORT MODEL FOR FEMALE SEX WORKERS IN ZIMBABWE
The cluster randomised trial of microplanning is implemented as a community mobilisation approach among female sex workers (FSW) in Zimbabwe to generate evidence of its effectiveness and cost-effectiveness. Microplanning an innovative, peer led, data guided, community outreach approach tailored for the individual needs of FSW was developed by the Avahan India AIDS Initiative to strengthen peer mobilization and programme ownership. To fully utilise opportunities presented by this model, CeSHHAR adopted a microplanning approach-which is aimed at providing tailored support to FSWs dependant on their risk profile in a systematic manner that can be tracked and linked to health outcomes.
The study is being implemented in 22 sites, which were randomised 1:1 to receive either the intervention (microplanning) or the control (standard of care). The goal is to estimate the impact of the microplanning combination package (which includes additional training in microplanning, hotspot mapping, hotspot validation, social network mapping, caseload of 50-risk assessment, tracking based on risk profile and weekly support visits from outreach workers) on HIV incidence among FSWs in Zimbabwe. The control arm received basic peer education training and a case load of 20 women. Across the two arms, FSWs are encouraged to attend clinic regularly.
Data analysis will compare the rate of linkage to clinical services, HIV testing, initiation on PrEP or ART and retention in HIV care between the two arms. In addition, an in-depth process evaluation is being conducted to track program fidelity, reach, and impact
PRIORITIES FOR LOCAL AIDS CONTROL EFFORTS (PLACE) STUDIES
Collaborations: CeSHHAR, LSTM, the MeSH Consortium, NAC, MoHCC.
LSTM lead and PI – Professor Frances Cowan
CeSHHAR lead and Co-PI – Dr Fortunate Machingura
The PLACE (Priorities for Local AIDS Control Efforts) method is a new monitoring tool to identify high transmission areas and the specific sites within these areas where AIDS prevention programs should be focused. Population-based sero-surveys to empirically identify areas with high HIV incidence are rarely conducted due to cost, feasibility, loss to follow-up, and ethical concerns. This approach acknowledges that contextual factors are often associated with areas where HIV incidence is high. The PLACE methodology comes in timely at a time when methods for monitoring and evaluating AIDS prevention are urgently needed. Because resources for interventions are limited, there is an urgent need to focus interventions where they are most cost-effective. Epidemiologic theory identifies a crucial role in the HIV epidemic for high transmission areas (places with a high rate of new partnership formation). A barrier to the identification of high transmission areas (HTA’s) and development of informed sexual network-based interventions within HTA’s has been the lack of rapid, reliable, and valid field methods for identifying area with high rates of new sexual partnership formation.
In Zimbabwe, we are aiming to increase local capacity to understand the drivers of local HIV epidemics, identify gaps in services among those most likely to acquire and transmit HIV, and provide evidence to support tailored interventions to reduce HIV transmission and improve access to treatment. We are working jointly with the MoHCC and NAC supporting capacity strengthening for local districts to subsequently do this in later years using available epidemiologic and contextual information to identify areas likely to have a higher incidence of HIV infection.
Our subsequent steps will employ rapid field methods to identify and characterize sites within these areas where people with many new sexual partners can be reached for prevention interventions. Characteristics of people socializing at sites are also obtained. Finally, the information is used to inform interventions in the area. The method focuses on places where new sexual partnerships are formed because the pattern of new partnerships in a community shapes its HIV epidemic. A PLACE based approach has programmatic advantages. Approaches based on risk group status, such as being a trucker or sex worker, can be stigmatizing and often inadequate in generalized epidemics. Clinic-based approaches miss most people with high rates of new sexual partner acquisition.
ENHANCED TRACING AND ENGAGEMENT STUDIES
Collaborations: CeSHHAR Zimbabwe, AMETHIST Consortium, LSTM, LSHTM,
Funders: Wellcome Trust, BMGF
LSTM lead and PI – Professor Frances Cowan
CeSHHAR lead and Co-PI – Dr Fortunate Machingura
We are adapting, “tracing studies” to physically and digitally track female sex workers who have been lost to follow up (LTFU) from our sex worker clinical services, bringing them back to care, and additionally improving accuracy of measurement of outcomes including LTFU, reengagement, retained on ART among other variables. We aim to better understand whether FSW who stop attending Sister’s clinic services remain in need of HIV prevention and treatment services. We trace women who appear to be no longer accessing Sisters services. We will assess the proportion of women who appear to be lost to follow up from the sisters outreach clinic for 6 months or more who remain in need of ‘Sisters’ services. We will also assess the proportion in need of services who re-engage with Sisters, and whether this differs across three purposively selected sites.
The enhanced tracing process and associated record keeping are in line with normal programme goals and activities (the programme currently actively follows up women on ART or PrEP who default from care), and as such this is a programmatic intervention.
LONG-ACTING CABOTEGRAVIR (CAB LA) AND DAPIVIRINE VAGINAL RING (DPV VR) FOR HIV PREVENTION AMONG FEMALE, MALE AND TRANSGENDER SEX WORKERS IN ZIMBABWE: VALUES AND PREFERENCE STUDIES.
Collaborations: World Health Organisation (WHO), Ministry of health and Child Care, National AIDS Council
Funder: WHO Geneva
LSTM lead and PI – Professor Frances Cowan
CeSHHAR lead and Co-PI – Dr Fortunate Machingura
In collaboration with WHO, MoHCC and NAC we are exploring values and preferences for long-acting pre-exposure prophylaxis (PrEP) choices, including cabotegravir (CAB LA) and Dapivirine vaginal ring (DPV VR) and delivery options among female, male and transgender sex workers in Zimbabwe. The study is nested within Zimbabwe’s nationally scaled Sister’s programme for sex workers. We are conducting Discrete Choice Experiments (DCE) using qualitative research methods whilst developing surveys, particularly for elicitation of attributes. We are conducting cognitive debriefing interviews to evaluate survey comprehension of choice tasks. The DCE is embedded within a large RDS survey.
PrEP is one of the five prevention pillars of the UNAIDS prevention strategy “HIV Prevention 2020 Road Map – Accelerating HIV prevention to reduce new infections by 75%.” UNAIDS aimed for 3 million people globally to be taking oral PrEP by 2020. This target was missed by a substantial amount although there are now encouraging increases in the rate of uptake of PrEP among those at highest risk of HIV. In sub-Saharan Africa and in other LMIC, while rate of oral PrEP initiation is increasing, the rate of PrEP continuation and adherence remains low. New technologies which remove or reduce many of the barriers to adherence to a daily oral pill are required.
The results from the HIV Prevention Trials Network (HPTN) 083 trial, released in 2020, demonstrated early superiority of long acting injectable cabotegravir (CAB LA) over daily oral Tenofovir/ emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for HIV, creating potential to add a new and highly effective prevention option to existing programmes. The HPTN 083 trial, showed that CAB LA lowered HIV incidence among participants compared to daily oral TDF/FTC. Cabotegravir is an integrase inhibitor, the same class of drugs that includes the widely used treatment drug dolutegravir and is formulated as an injectable for long-lasting pre-exposure prophylaxis (PrEP). Separately injectable cabotegravir in combination with injectable rilpivirine has been developed as a treatment option to maintain virologic suppression in people living with HIV.
Separately, the results from IPM 027, a Phase III, multi-centre, double-blind, randomized, placebo-controlled trial showed that a monthly vaginal ring (Ring-004), containing 25 mg Dapivirine reduced the risk of HIV infection by 30.7% relative to placebo with a 37.5% reduction in HIV infection among women older than 21 years. The Dapivirine ring is an intravaginal silicone ring for HIV prevention. Over the course of one month, the ring slowly delivers Dapivirine, an antiretroviral drug directly to vaginal tissue to help protect against HIV. While less effective than CAB LA or daily oral TDF/FTC it does provide an important alternative option for women unable to tolerate daily pill taking or two monthly injections. Importantly Dapivirine Vaginal Ring-004 is safe and is now prequalified for use by WHO if women feel unable to use oral PrEP for any reason. In addition, it has recently been registered for use in Zimbabwe.
HIV RECENCY STUDIES: RITA (RECENT INFECTION TESTING ALGORITHM)
Collaborations: MeSH consortium.
LSTM lead and PI Zimbabwe: Professor Frances Cowan
Zimbabwe Co-PI: Dr Fortunate Machingura
We are deploying RITA (Recent Infection Testing Algorithm), a combination of laboratory tests used to classify an HIV infection as recent or long- term. The study is nested within the national sex work programme in 57 clinic sites. RITA helps to reduce false recent classification when individuals are on ART or elite controllers. If a client tests recent on the RTRI, we conduct viral load (VL) testing to improve accuracy of classification. The addition of VL reduces potential false recent cases due to extended ART or weak antibody responses in elite controllers.
Viral load testing is most useful in combination with the RTRI for final determination of recent infection status. Those who test recent on the RTRI and have a viral load ?1,000 copies/mL are classified as RITA-recent. Our RITA study assesses the feasibility and utility of HIV infection recency testing among Female Sex Workers for the purposes of predicting the risk of recent HIV infection and targeting prevention efforts. We are exploring the causal pathways of risk to strengthen the national sex work programme, by potentially identifying hotspots of new infection for geographic targeting of interventions.
LONGITUDINAL AND LIFE-COURSE STUDIES
The Longitudinal life course studies seek to understand the individual characteristics that predict effective engagement in HIV prevention and care among Zimbabwean female sex workers. The studies explore how these characteristics vary as women transition into and out of sex work. Lack of enough information and understanding of these transitions have implications for optimizing programme implementation, target setting and model parameterisation. The Longitudinal and Life-Course Studies are being conducted in two large urban districts in Zimbabwe (Harare and Mutare).
LIFE NARRATIVES RESEARCH
Using life narratives as both a data gathering and analytical framework, we seek to understand female sex worker transitions into and out of sex work, seasons of risk and experience of general HIV care and prevention and targeted sex work interventions at different phases of their lives. FSW’s lived stories capture the complexities and nuanced understanding of their significant experiences. In addition, we are also exploring risk environment in which they live and work as well as their resilience. The research is implemented over a year and these data will be used to enhance microplanning /community support for FSW and better parameterise the Zimbabwe model.