Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007818077777 Date of Approval: 02/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title AMETHIST (Adapted Micro planning: Eliminating Transmissible HIV In Sex Transactions) Trial
Official scientific title 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 Micro planning: Eliminating Transmissible HIV In Sex Transactions)
Brief summary describing the background and objectives of the trial Female sex workers (FSW) are 11 times more likely to be infected with HIV compared to adult women in the general population, and more than half of all new HIV infections stem from key populations, including FSWs. Population size estimates suggest 40,000 FSW (1.13% of adult female population) in Zimbabwe have an HIV prevalence of 58% and 7-10% annual incidence, 20 times that of adult women (Cowan et al. 2017). Malawi and Durban in South Africa estimate 62.7% and 54% HIV prevalence among FSW, respectively (UNAIDS Estimates 2019). Uptake of health services among FSWs is suboptimal, resulting in poorer HIV and other health-related outcomes. Evidence shows that combining microplanning and community empowerment will raise uptake and adherence to prevention and treatment among FSWs to levels that can lead to the elimination of HIV transmissions in sex transactions in cost-effective and translatable ways. This trial aims to develop and evaluate a micro-planning intervention for Africa and deepen the understanding of how to optimise the implementation and determine population impact and cost-effectiveness. The trial objectives 1) To determine if AMETHIST intervention (microplanning supported by the formation of self-help groups) can be implemented at scale with sufficient intensity and coverage to reduce the proportion of sex workers at risk of HIV acquisition or transmission, 2) To determine the cost-effectiveness of the AMETHIST intervention, 3) To determine whether the AMETHIST intervention builds community empowerment.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) AMETHIST
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 29/01/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 4400
Actual target sample size (number of participants) 4400
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Microplanning HIV prevention and care differentiated community support model for FSW in Zimbabwe The intervention will run for two years with the following doses and frequency: 1. Hotspot mapping - once every six months to systematically conduct size estimations, understand FSW needs and offer differentiated support and care in their respective areas. 2. Microplanning - Regular, risk differentiated and structured one to one contact with peers with each Microplanner responsible for at least 50 FSW - weekly for women with high risk, every two weeks for women with medium risk and monthly for low risk. 3. Follow up visits - Woman not being tracked as required may get a visit from the outreach worker and Microplanner to understand her situation - regularly and as needed 4. Clinical service uptake - FSW are encouraged to visit the clinic for service uptake once every three months. The intervention arm will provide usual care through the sex work programme. The programme provides free condoms and contraception, provider-initiated HIV testing and counselling, HIV self-testing and counselling (and secondary distribution of self-test kits for partners), syndromic management of sexually transmitted infections, health education and legal advice. Additionally, clinics are providing long-acting reversible contraception (implant), referral for cervical cancer screening and on-site access to PrEP. Women who test positive for HIV are referred to government services for HIV care/ART initiation. 5. Self-help groups (SHG) - at least one SHG per hotspot composed of 10-15 women who meet twice a month, created by FSW - to strengthen solidarity and discuss prevention, testing and treatment interventions and negotiate identities and norms (through participation in self-help groups) 2 years The intervention provides usual care augmented by microplanning and establishment of self-help groups (SHGs). Peer educators receive basic peer education training for one week and further training in microplanning, facilitating SHGs and become Empowerment Workers (EWs). Each EW is allocated a specific hotspot where she enumerates all FSW working at her allocated hotspot. She provides each FSW she identifies a Sisters ID number (or recording her Sisters ID number if the FSW has already attended the Sisters programme). She meets with each FSW in her hotspot regularly (known as tracking). Once the EW worker has developed a relationship with an FSW, she assesses risk. Regular, risk differentiated and structured one to one contact with peers (through microplanning) nudges FSW and their networks to reflect on what they need to stay safe. EW is responsible for microplanning about 50 FSW in a hotspot. EWs conduct a risk assessment using the risk assessment tool. Tracking of FSW is based on a risk assessment score, weekly for women with high risk, every two weeks for medium risk and monthly for low risk. A weekly report is generated, showing which woman to visit, their needs and priority discussion topics in that week. If a woman is not being tracked as required, the ORW and or EW follows up and may visit the woman. EW encourage all FSW in their hotspot to get a clinical review every three months (HIV testing, PrEP /ART initiation and or adherence support, STI screening and treatment ). Women who test HIV+ are referred to services for HIV care/ART initiation. 10-15 FSW are encouraged to establish self-help groups (SHGs), meet twice a month to strengthen solidarity and discuss prevention, testing and treatment interventions and negotiate identities and norms (through participation) EWs conduct hotspot mapping in geographic locations where FSW congregate to work, validate hotspots and perform network mapping once every six months to conduct size estimations systematically. 11
Control Group Usual Care 2 years Uptake Clinical Services: The programme is supported by peer educators who mobilise FSW to attend clinical services and encourage uptake of HIV testing and support the referral of FSW for ART and PrEP as appropriate. Uptake of clinical services: programme provides free condoms and contraception, provider-initiated HIV testing and counselling, HIV self-testing and counselling (and secondary distribution of self-test kits for partners), syndromic management of sexually transmitted infections, health education and legal advice. Additionally, clinics are providing long-acting reversible contraception (implant), referral for cervical cancer screening and on-site access to PrEP. Women who test positive for HIV are referred to government services for HIV care/ART initiation. 11 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any sex workers regardless of age, gender or place of residence can attend the programme at any AMETHIST trial site (intervnetion or control). Eligibility for the outcome survey in June 2021. • Female • Age 18 or older • Currently working as a sex worker (has exchanged sex for money in the past 30 days) • Living or working in the study site (for at least 1 month). The following are in eligible for the outcome survey in June 2021. • Male or transgender • Under 18 • Already participated in the current round of the survey • Visiting the study site temporarily (for less than 1 month) • Not currently working as a sex worker (verification questions will be used to prevent fraudulent participation, such as about how sex work is organised in the area and the cost of different sex acts) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/02/2020 Liverpool School of Tropical Medicine Reserach Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA Liverpool 0044 United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/02/2020 Medical Research Council Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Corner Joshua Tongogara and Mazowe Street, Harare Harare 00000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome % of all FSW recruited to RDS survey who are HIV negative and who are not taking PrEP and report condomless sex in the past month (i.e. at risk of HIV acquisition) OR who are HIV positive and have Viral Load > 1,000copies/µl and report condomless sex in the past month (i.e. who are at risk of HIV transmission). 24 months.
Secondary Outcome % of all FSW recruited to the RDS survey who are HIV negative and who are not taking PrEP (verified by drug levels - at risk of HIV acquisition ) OR who are HIV positive and have Viral Load > 1,000copies/µl (i.e. who are at risk of HIV transmission). 24 months
Secondary Outcome % of all FSW recruited to the RDS survey who have had contact with the Sisters programme in the last year and who are HIV negative and who are not taking PrEP and report condomless sex in the past month. (i.e. at risk of HIV acquisition) OR who are HIV positive and have Viral Load > 1,000copies/µl and report having condomless sex in the past month (i.e. who are at risk of HIV transmission). 24 months
Secondary Outcome % of FSW who enrolled in AMETHIST intervention compared with individually matched controls who are either HIV negative and who are not taking PrEP and report condomless sex in the past month (i.e. at risk of HIV acquisition) OR who are HIV positive and have Viral Load > 1,000copies/µl and report having condomless sex in the past month (i.e. who are at risk of HIV transmission). 24 months
Secondary Outcome The proportion of those taking ART who have viral load >1000 and have drug resistance to their current regimen 24 months
Secondary Outcome Self-reported quality of life, psychological health and functioning 24 months
Secondary Outcome Perceived levels of peer support 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre of Sexual Health and HIV AIDS Research Zimbabwe 4 Bath Road Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Gibbs Building 215 Euston Road London NW1 2BE UK London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA Liverpool 0044 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Professor Frances.M.Cowan Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA Liverpool United Kingdom
Professor James Hargreaves London School of Hygiene and Tropical Medicine 15-17 Tavistock Place, Kings Cross, London WC1H 9SH London United Kingdom
Associate Professor Joanna Busza London School of Hygiene and Tropical Medicine 15-17 Tavistock Place, Kings Cross, London WC1H 9SH London United Kingdom
Amon Mpofu National AIDS Council Zimbabwe 100 Central Ave, Harare Harare Zimbabwe
Dr Fortunate Machingura Centre for Sexual Health and HIVAIDS Research CeSHHAR Zimbabwe 4 Bath Road, Belgravia Harare Zimbabwe
Professor Paul Revill University of York York United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frances Cowan frances.cowan@lstmed.ac.uk +447833654598 Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA
City Postal code Country Position/Affiliation
Liverpool United Kingdom Professor of Global Health
Role Name Email Phone Street address
Scientific Enquiries James Hargreaves james.hargreaves@lshtm.ac.uk +442079272955 London School of Hygiene and Tropical Medicine 15-17 Tavistock Place, Kings Cross, London WC1H 9SH UK
City Postal code Country Position/Affiliation
London United Kingdom Professor of Epidemiology
Role Name Email Phone Street address
Public Enquiries Fortunate Machingura fmachingura@ceshhar.co.zw +263772971481 4 Bath Road, Belgravia
City Postal code Country Position/Affiliation
Harare Zimbabwe Research Director Key Populations
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will support data access to the anonymised datasets likely to have scope for wider research use. Clearly data collected from sex workers who are criminalised (and at times persecuted by the legal system in Zimbabwe) can only be shared when appropriate measures to ensure individual and location confidentiality. Data collected will include i) In Zimbabwe, programme data collected by microplanners and clinic staff to record all microplanning, self help group and clinic interactions. All FSW attendees at the Sisters programme are given a Unique Identifier Code to allow confidential tracking across service components. ii) In Zimbabwe, individual-level outcome data for 4,440 respondent driven sampling survey participants, living around the 22 Sisters clinics, randomised in the trial, collected in the last quarter of 2020. Each participant will complete an interviewer-administered questionnaire and have dried blood spot specimens collected for HIV testing, HIV viral load testing, recency testing. A random half of the participants will have a vaginal swab taken for STI screening. iii) In Zimbabwe, qualitative data will be collected as part of the process evaluation of the AMETHIST intervention to elicit perceptions of the feasibility and acceptability of the intervention and their satisfaction and perspectives on its quality. Discussions will be informed by topic guides and will be conducted in Shona, the participants' language. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 2 years of completion of data collection - Anticipated July 2023 At the time of publication of research, the subset of the data required for the purposes of verifying research findings will be available for sharing on request. Fuller sharing of data with any group requesting access to individual records will be ensured within 24 months of completion of studies. We will aim to hold the anonymised data for sharing as original databases stored with a soft copy of the fully annotated questionnaires and the STATA files used for recoding and analysis. Ethical clearance will be sought before data are transferred to other groups for secondary analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information