Effect of pre-exposure prophylaxis (PrEP) on risky sexual behaviours of female sex workers in Dakar, Senegal
| ISRCTN | ISRCTN16445862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16445862 |
| Secondary identifying numbers | 17341/001 |
- Submission date
- 11/03/2021
- Registration date
- 11/03/2021
- Last edited
- 11/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
PrEP (pre-exposure prophylaxis) is medicine people at risk for HIV take to prevent them from getting HIV. Senegal is in the process of rolling out PrEP gradually nationally. Female sex workers are one of the target groups for PrEP due to their high risk of contracting HIV. However, there is also a policy concern that taking PrEP might reduce their incentives for using a condom, especially when unprotected sex has higher renumeration. This may have public health consequences as condom use also curbs the transmission of other sexually-transmitted infections (STIs). Therefore, this study aims to study whether the drop in condom use is large enough to be of concern, and if possible, among which groups this drop is concentrated in.
Who can participate?
Female sex workers aged 18 and over who took part in the July 2020 wave of a panel survey held in Dakar, Senegal who are still working in sex work at the point of that survey
What does the study involve?
Survey respondents are randomly allocated into the treatment group and the control group. The contact details of survey respondents allocated to the treatment group are given to the partner organisation rolling out PrEP. This gives them a potential pool of female sex workers whom they can contact to explain what PrEP is, and how they can receive PrEP. If a respondent is interested in PrEP, she is required to visit one of the associated clinics where PrEP is offered in order to check her eligibility. Part of this process involves a HIV test and a kidney function test as seronegativity and sufficient kidney function are necessary for PrEP usage. If a respondent is found to be eligible, it will be possible for her to take PrEP. The contact details of the survey respondents allocated to the control group are not given to the partner organisation. To better reach female sex workers, the partner organisation rolling out PrEP will be adopting mobile clinics as their key strategy for dispensing PrEP. The outcomes of the study will be collected with a survey after PrEP has been offered to the treatment group. Condom use with each of the last two clients and the last five clients will be measured with a combination of these methods: direct questioning, a list experiment, as well as via a new instrument aiming to elicit individual condom use without compromising the confidentiality of the respondent. Subjective perceptions of the necessity of condom use will also be collected. The survey will also measure the number of clients, perceived risk of clients, price of last two clients, type of sex acts with the last two clients, whether the respondent stayed overnight with the last two clients, earnings from sex work, household expenditure, food insecurity, self-reported STI symptoms with the last two clients, and mental health.
What are the possible benefits and risks of participating?
PrEP is an established treatment with proven high effectiveness against HIV. Taking up PrEP treatment typically involves short-term side-effects, such as nausea, tiredness, vomiting, dizziness, and headaches, that tend to be relatively mild and lessen over time. Longer-term side effects may involve kidney function and reduction in bone mineral density. A test for sufficient kidney function as a prerequisite for eligibility for PrEP. Regular follow-up visits provide the opportunity for monitoring the health of those on PrEP.
Where is the study run from?
1. Alliance Nationale des Communautés pour la Santé (ANCS) (Senegal)
2. Ministry of Health and Social Action (Senegal)
3. University College London (UCL) (UK)
4. Erasmus University Rotterdam (Netherlands)
When is the study starting and how long is it expected to run for?
July 2019 to March 2022
Who is funding the study?
1. MRC Public Health Intervention Development Scheme (UK)
2. D.P. Hoijer Fonds, Erasmus Trustfonds, Erasmus University Rotterdam (Netherlands)
Who is the main contact?
Aurélia Lépine
a.lepine@ucl.ac.uk
Contact information
Scientific
University College London
Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7905 2646 |
|---|---|
| a.lepine@ucl.ac.uk |
Public
University College London
Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7905 2646 |
|---|---|
| a.lepine@ucl.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Randomized controlled trial of the effect of pre-exposure prophylaxis on risky sexual behaviours of female sex workers in Dakar, Senegal |
| Study objectives | 1. Pre-exposure prophylaxis (PrEP) reduces the use of condoms among female sex workers. 2. PrEP reduces the perceived necessity of the use of condoms among female sex workers. |
| Ethics approval(s) | Approved 22/05/2020, UCL Research Ethics Committee (Office of the Vice Provost Research; 2 Taviton Street University College London; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: 17341/001 |
| Health condition(s) or problem(s) studied | Prevention of HIV and other sexually transmitted infections (STIs) |
| Intervention | The study randomises respondents into a treatment arm and a control arm. This randomisation is stratified according to two criteria: 1) prior use of PrEP and 2) self-reported risk preferences in sex. A respondent is deemed to have prior use of PrEP if she answered in any of the previous survey waves in 2017 and 2020 that she took part in the 2015-2016 PrEP demonstration project in Senegal. Respondents are asked to self-report their risk preferences in sex on a Likert-like scale in the July 2020 survey waves. This forms the basis to categorise respondents into a high risk and a low-risk group. After the control and the treatment lists were generated, to account for the possibility of recruitment caps by the partner organisation rolling out PrEP, the participants the treatment list were ordered such that the proportion of each strata was as close to that of the control group as possible. This ensures that if participants were called in order, and recruitment stops at some point in the list, the balance of stratified characteristics of those who were contacted and the control group remains similar. If there were to be no limitations on recruitment, following this order will not be necessary. The contact details of survey respondents allocated to the treatment group are given to the partner organisation rolling out PrEP. This gives them a potential pool of female sex workers whom they can contact to explain what PrEP is, and how they can receive PrEP. PrEP will be distributed via multiple avenues, primarily through mobile clinics. The contact details of the survey respondents allocated to the control group are not given to the partner organisation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Measured with a survey expected to be held 3 months after the roll-out of PrEP: 1. Condom use with each of the last two clients and the last five clients measured via a combination of these methods: 1.1. Via direct questioning 1.2. Via list experiment 1.3. Via a newly-designed instrument aimed at eliciting individual condom use without compromising respondent confidentiality 2. Subjective perceptions of the necessity of condom use measured using a Likert-like scale |
| Secondary outcome measures | Measured with a survey expected to be held 3 months after the roll-out of PrEP: 1. Number of occasional and regular clients seen in a fixed time frame, e.g. 7 days 2. Perceived HIV risk of clients 3. Price of each of the last two clients 4. Type of sex acts with last two clients/stayed overnight with last two clients 5. Earnings from sex work in a fixed time frame, e.g. 30 days 6. Household expenditure in a fixed time frame, e.g. 30 days 7. Food insecurity 8. Self-reported STI symptoms with last two clients 9. Mental health measured using the PHQ-9 questionnaire |
| Overall study start date | 01/07/2019 |
| Completion date | 13/05/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 500 |
| Total final enrolment | 500 |
| Key inclusion criteria | 1. Female sex workers who participated in the July 2020 survey wave of a female sex worker panel survey 2. Female sex workers who in the July 2020 survey wave responded that they are still doing sex work |
| Key exclusion criteria | If it was recorded in any of the past three survey waves held in 2015, 2017 and 2020 that the female sex workers has a medical record that indicates seropositive status |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Senegal
Study participating centres
25000
Senegal
17000
Senegal
17000
Senegal
20200
Senegal
Sponsor information
University/education
Gower Street
Bloomsbury
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)20 7679 2000 |
|---|---|
| uclh.jro-communications@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
University/education
Burgemeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
| Phone | +31 (0)10 408 1111 |
|---|---|
| toh@ese.eur.nl | |
| Website | http://www.eur.nl/english/ |
|
"ROR" |
https://ror.org/057w15z03 |
Other
Cité Keur Gorgui Villa 41Dakar
Dakar
10297
Senegal
| Phone | +221 (0)33 869 30 11 |
|---|---|
| ancs@ancs.sn |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. A formal study protocol and statistical analysis plan are not available. Any publication eventually would include the finalised study protocol. |
| IPD sharing plan | Deanonymised data will be publicly available via the UCL research data repository (https://rdr.ucl.ac.uk) after the publication of the paper. Consent from participants will be obtained during the survey. |
Editorial Notes
11/07/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2022 to 13/05/2022.
2. The intention to publish date was changed from 30/06/2022 to 31/12/2022.
3. The total final enrolment was added.
3. The plain English summary was updated to reflect these changes.
17/06/2021: The following changes have been made:
1. The recruitment start date has been changed from 15/03/2021 to 01/07/2021.
2. The recruitment end date has been changed from 15/06/2021 to 31/10/2021.
3. The overall trial end date has been changed from 31/07/2021 to 31/03/2022 and the plain English summary has been updated to reflect this change.
4. The intention to publish date has been changed from 31/12/2021 to 30/06/2022.
08/04/2021: Sponsor contact details updated.
11/03/2021: Trial's existence confirmed by the UCL Research Ethics Committee.
