Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa:A Cluster Randomized Controlled Trial (CRCT).Release Version 5
South Africa, 2019 - 2023
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AHRI.STAR.2019.v5
Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa:A Cluster Randomized Controlled Trial (CRCT).Release Version 5
| Name | Country code |
|---|---|
| South Africa | ZA |
This study seeks to test the hypothesis that HIV-SS will allow peer delivered or peer led networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.
Study Objectives:
- To increase the knowledge of HIV status among young women aged 18-24 years old and their male partners through distribution of HIV-SS through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
- To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-SS through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
- To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-SS distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
- To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-SS delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.
Peer navigator outreach activities (HIV-SS and referral slips distribution) and clinic (attendance) data
Data collected by peer-navigators will be summarised by cluster (peer-navigator pair).
Version
V5.0.0
Scope
| Topic | Vocabulary | URI |
|---|---|---|
| HIV-1; Incidence; Phylogeny; Epidemics; Population Surveillance; Rural Population; HIV Infections; Africa | Africa Health Research Institute | www.ahri.org |
Coverage
Demographic surveillance area of the Africa Health Research Institute.
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
| Name | Affiliation |
|---|---|
| Maryam, Shahmanesh | University College London |
| Pillay, Deenan | Africa Health Research Institute |
| Name |
|---|
| Africa Health Research Institute |
| Name | Role |
|---|---|
| South African Medical Research Council | Genotyping funding source |
| Name | Affiliation | Role |
|---|---|---|
| Wilkinson, Eduan | KwaZulu-Natal Research Innovation Sequencing Platform | Cleaned, aligned and help analyse the sequence data |
Sampling
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
| Start | End |
|---|---|
| 2019-03-15 | 2023-01-10 |
Data processing
From Peer Navigator Monitoring Tool:
PeerNavIssueSTARPackages:
Contains all participant who agreed to participate in STAR and all associated variables capturing the distribution of packages between all 3 study arms.
Linking to other datasets:
The Unique QR Code of the Package will link with the Unique QR Code of the Referral slip of those participants linking to the clinic in the PrEP Clinic Participant Management System.
Linking to the ThethaNamiInformation dataset are done on the unique variable: PN_SurveyRecord.
Linking to the PeerNavInfo datasets on the unique variable: PeerNavCode
ThethaNamiInformation:
Contains information on all participants with whom the PNs interacted with, including the STAR participants, and the Thetha Nami Questionnaire.
Linking to other datasets:
Linking to the STARPackageDistribution dataset are done on the unique variable: PN_SurveyRecord.
Linking to the PeerNavInfo datasets on the unique variable: PeerNavCode
PackageDistribution:
Contains the Package distribution information in a short format
Linking to other datasets:
Linking to the PeerNavInfo datasets on the unique variable: PeerNavCode
Linking to the STARPackageDistribution and ThethaNamiInformation datasets are done on the unique variable: PN_SurveyRecord.
Linking to PrEP Clinic Participant Management System is done on the Unique QR Code of the Package will link with the Unique QR Code of the Referral slip of those participants linking to the clinic.
From Peer Navigator Activity Log:
PeerNavActivityLog:
Summary of the amount to time PNs spent on the project on a daily basis. Contains start and stop times of each shift the PNs worked
Linking to other datasets:
Linking to the PeerNavInfo datasets on the unique variable: PeerNavCode
From PrEP Clinic Participant Management System:
PersonalDetails:
Personal details plus linking information to the STAR Package Distribution project are combined in this dataset. Contains one record per participant
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord
Linking to STARPackageDistribution and PackageDistribution on the variable: STARRefQRCode
ClinicVisits:
Contains one record per participant per visit. Some visits are linked to telephone calls and not clinic attendance. The participants attendance are indicated by variable: ClinicAttended. This dataset also includes the different reason for visiting the clinic on that day.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
Consents:
All consent forms and questions are combined into this dataset. Contains one record per participant for each question asked on each Informed Consent form they completed.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord
ClinScreenHealthPro:
Contains one record per participant, visit and Clinical Screening question asked. This included all questions from the following questionnaires:
Registration Questions
Clinical Screening - Alcohol Consumption
Health Promotion - Choice of contraception and condoms
Clinical Screening - Drug Use
Clinical Screening - HIV Testing history
Clinical Screening - HPV vaccine history
Health Promotion - Multiple health-related behaviors that will affect fertility and sexual pleasure
Clinical Screening - PMH / DH / Allergies
Health Promotion - Preconception advise and Contraception counselling
Clinical Screening - Population Association
Clinical Screening - Referral to DoH
Clinical Screening - Reproductive History / Pregnancies
Clinical Screening - Reproductive Tract Symptoms
Clinical Screening - Sexual history
Clinical Screening - Tobacco Consumption
Clinical Screening - TB Screening
Clinical Screening - Circumcision [Men]
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
·ClinScreenHealthPro_Long:
Contains one record per participant and visit in a Long format. This included all questions from the following questionnaires:
Registration Questions
Clinical Screening - Alcohol Consumption
Health Promotion - Choice of contraception and condoms
Clinical Screening - Drug Use
Clinical Screening - HIV Testing history
Clinical Screening - HPV vaccine history
Health Promotion - Multiple health-related behaviors that will affect fertility and sexual pleasure
Clinical Screening - PMH / DH / Allergies
Health Promotion - Preconception advise and Contraception counselling
Clinical Screening - Population Association
Clinical Screening - Referral to DoH
Clinical Screening - Reproductive History / Pregnancies
Clinical Screening - Reproductive Tract Symptoms
Clinical Screening - Sexual history
Clinical Screening - Tobacco Consumption
Clinical Screening - TB Screening
Clinical Screening - Circumcision [Men]
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
VitalSigns:
Vital Signs measurements including, height and weight. Contains one record per participant and visit.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
PrEPEligibilityCheck:
Summary of all eligibility checks for participants wanting to start PrEP. Eligibility checks are repeated at each visit before dispensing medication. Contains one record per participant and visit.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
TestResults:
Contains one record per participant, visit and Test Result for point of care tests and Laboratory tests.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
Medications:
Contains one record per participant, visit and type of Medication dispensed. This dataset contains the following medication types:
STI Treatment
PrEP Treatment
ART Treatment
Contraceptive Treatment
Other Treatment
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
DrugAccountability:
Contains one record per participant and visit for PrEP Treatment.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
ClinicAttendPrEPOverview
Contains a summary of PrEP Eligibility Outcomes and PrEP Medication dispensing during the study. This dataset contains one record per participant.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
PhoneCalls:
Contains on record per participant, visit and telephone contact attempt. This dataset contains the following types of telephone calls:
Visit Reminder Phone Call
7 Day Follow Up Phone Call
Tracking Lost to Follow Up Phone Call
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
AdverseEvents:
Contains one record per participant and visit, determining if there were any Adverse Events to report or not.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
EndOfStudy:
Collected at the end of each visit to determine if the participant is continuing to the next visit or to provide the reasons for ending the study. Contains one record per participant and visit.
Linking to other datasets:
Linking to other Participant Management System dataset on variable: SurveyRecord and VisitId for those datasets with visits
Additional datasets:
PeerNavInfo:
Contains the data on the PNs assigned Local Areas (Isigodis) and Study Arms
Linking:
Linking to the STARPackageDistribution, ThethaNamiInformation and PackageDistribution datasets on the unique variable: PeerNavCode
Data Access
The representative of the Receiving Organization agrees to comply with the following conditions:
- Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
- 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.
- 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.
- 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.
- 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.
Shahmanesh, M., & Deenan, P. (2023). Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa:A Cluster Randomized Controlled Trial (CRCT).Release Version 5 [Data set]. Africa Health Research Institute.
DOI:https://doi.org/10.23664/AHRI.STAR.2019.V5
Metadata production
DDI.AHRI.STAR.2019.v5
| Name |
|---|
| Africa Health Research Institute |