STAR–Sharing of PrEP participant data with the WHO
South Africa, 2019 - 2020
Dr Maryam, Shahmanesh, Pillay, Deenan,
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November 18, 2020
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November 18, 2020
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Identification
Survey ID Number
AHRI.STAR.WHO.PrEP.Data
Title
STAR–Sharing of PrEP participant data with the WHO
Country
| Name | Country code |
|---|---|
| South Africa | ZA |
Abstract
Background
In 2015, WHO published a recommendation on the use of antiretroviral medications for PrEP as an additional prevention choice for individuals at substantial HIV risk. WHO subsequently published modular implementation guidance (a tool) in 2017 to assist countries with introducing PrEP into their health systems. Since the publication of the WHO recommendation and the implementation tool, further positive clinical research findings from studies in men who have sex with men on the use of event-driven ('on-demand') dosing have been published. Key population groups such as men who have sex with men and transgender women are at particularly high risk of HIV globally, and may benefit from a shorter PrEP regimen (4 pills in total taken before and after a sexual exposure, rather than daily dosing.
PrEP is a comparatively new intervention, and data on related toxicities such as renal toxicity among healthy individuals has been limited but is growing. WHO would like to review the evidence on renal function relating to ARVs used in PrEP in order to inform an update to the clinical module on the frequency of creatinine monitoring required.
The results from these literature and clinical data reviews will used to update WHO PrEP clinical guidance and will be included in updated ARV guidelines to be published in 2020. WHO is conducting a systematic review of the available evidence on renal function related to PrEP use. However, the evidence is limited and the number of publications that present results by age or over time are few. Since studies and programs implementing PrEP routinely screen for renal function using creatinine screening, WHO is now requesting de-identified individual patient data from Principal Investigators and PrEP programs that contain the information needed but are not yet published, in order to conduct pooled analyses and generate evidence for updated guidance.
Purpose of analyses
The purpose of this analysis is to review the data on creatinine clearance and screening frequency among PrEP users to inform WHO PrEP clinical guidance for the frequency of creatinine screening.
In 2015, WHO published a recommendation on the use of antiretroviral medications for PrEP as an additional prevention choice for individuals at substantial HIV risk. WHO subsequently published modular implementation guidance (a tool) in 2017 to assist countries with introducing PrEP into their health systems. Since the publication of the WHO recommendation and the implementation tool, further positive clinical research findings from studies in men who have sex with men on the use of event-driven ('on-demand') dosing have been published. Key population groups such as men who have sex with men and transgender women are at particularly high risk of HIV globally, and may benefit from a shorter PrEP regimen (4 pills in total taken before and after a sexual exposure, rather than daily dosing.
PrEP is a comparatively new intervention, and data on related toxicities such as renal toxicity among healthy individuals has been limited but is growing. WHO would like to review the evidence on renal function relating to ARVs used in PrEP in order to inform an update to the clinical module on the frequency of creatinine monitoring required.
The results from these literature and clinical data reviews will used to update WHO PrEP clinical guidance and will be included in updated ARV guidelines to be published in 2020. WHO is conducting a systematic review of the available evidence on renal function related to PrEP use. However, the evidence is limited and the number of publications that present results by age or over time are few. Since studies and programs implementing PrEP routinely screen for renal function using creatinine screening, WHO is now requesting de-identified individual patient data from Principal Investigators and PrEP programs that contain the information needed but are not yet published, in order to conduct pooled analyses and generate evidence for updated guidance.
Purpose of analyses
The purpose of this analysis is to review the data on creatinine clearance and screening frequency among PrEP users to inform WHO PrEP clinical guidance for the frequency of creatinine screening.
Unit of Analysis
Data collected by peer-navigators will be summarised by cluster (peer-navigator pair).
Version
Version Description
V1.0.0
Scope
Topics
| Topic | Vocabulary | URI |
|---|---|---|
| HIV-1; Incidence; Phylogeny; Epidemics; Population Surveillance; Rural Population; HIV Infections; Africa | Africa Health Research Institute | www.ahri.org |
Keywords
| Keyword | Vocabulary | URI |
|---|---|---|
| HIV-Self testing, peer outreach work, HIV prevention, PrEP, ART | Africa Health Research Institute | www.ahri.org |
Coverage
Geographic Coverage
Demographic surveillance area of the Africa Health Research Institute.
Universe
The study population include 24 pairs of area (Ward/izigodi) based peer navigators working with over 2000 young people particularly young women aged 18-24 years. More than 2000 young people (males and females) will be reached during the trial in the 21 wards representing the study area.
Producers and sponsors
Primary investigators
| Name | Affiliation |
|---|---|
| Dr Maryam, Shahmanesh | Africa Health Research Institute |
| Pillay, Deenan | Africa Health Research Institute |
Producers
| Name |
|---|
| Africa Health Research Institute |
Funding Agency/Sponsor
| Name | Abbreviation | Role |
|---|---|---|
| South African Medical Research Council | SAMRC | Genotyping funding source |
Other Identifications/Acknowledgments
| Name | Affiliation | Role |
|---|---|---|
| Wilkinson, Eduan | KwaZulu-Natal Research Innovation Sequencing Platform | Cleaned, aligned and help analyse the sequence data |
Sampling
Sampling Procedure
Since the study is a cluster randomised control trial with three arms where all areas in the southern Population Intervention Platform (PIP) were included, no formal sampling was done. We estimated that ~500 age eligible 18-24 years olds will be enrolled per peer navigator team catchment area, of whom we anticipate at least 200, 18-24-year-old females will be handed a coupon (so cluster size at least 200). We calculated the sample size calculation using the primary outcome, the rate of linkage after 3 months among women ages 18-24 years. Using our existing data on uptake of HIV testing in the DREAMS interventions as well as our data on uptake of testing and linkage to HIV care in the demographic surveillance rounds of, we estimate that 1 woman will link per 7 months of peer educators outreach work time in the standard of care. With 7 peer educator pairs (or clusters) per arm and a cluster coefficient of variation (k) of 0.25, we have 80% power to detect a 100% increase in rate from 1 woman to 2 women per 7 months of follow-up, and 90% power to detect a 150% increase from 1 woman to 2.5 women per 7 months of follow-up. We have chosen policy and clinically relevant increases in linkage to care. Assuming additional clustering of the outcome within peer educators and increasing the coefficient of variation (k) to 0.35, we have 80% power to detect a 150% increase in rate from 1 woman to 2.5 women per 7 months of follow-up. All sample size calculations assume two-tailed statistical tests with alpha=0.05.
Data Collection
Dates of Data Collection
| Start | End |
|---|---|
| 2019-03-15 | 2020-06-30 |
Access policy
Access conditions
The representative of the Receiving Organization agrees to comply with the following conditions:
1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.
6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.
7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.
6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.
7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
Metadata production
DDI Document ID
DDI.AHRI.STAR.WHO.PrEP.Data
Producers
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |