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.: PACTR201809873079121 Date of Approval: 11/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An evaluation of the implementation of the CBCT Social Franchise HIV Counselling and Testing (HCT) model offered by FPD
Official scientific title An evaluation of the implementation of the CBCT Social Franchise HIV Counselling and Testing (HCT) model offered by FPD
Brief summary describing the background and objectives of the trial The purpose of the study is to evaluate the effectiveness and impact of the Social Franchise HIV counselling and testing (SFHCT) pilot project in Tshwane district. The study will evaluate if the Social Franchise as a mode of administering Community based HIV counselling and testing (CBCT) will optimally reach the targeted population and therefore achieve community HIV counselling and testing (HCT) saturation and provide evidence for successful linkage to care. This study will also assess the reasons why franchisees choose to participate in social franchising of CBCT and identify challenges and benefits that the franchisees face in conducting HCT and reaching people defined as key populations in HCT including linking them to care. In addition the evaluation will also ascertain if the use of the mobile electronic data management system improved linkage to care through easy documentation and retrieval of clients’ data for linkage to care purposes. The objectives are as follows: 1. To assess whether the pilot trial achieved its goals of increasing HCT to reach first time testers and key populations and increase linkage to care a. To determine whether giving franchisees incentives increased the uptake of HCT for first time testers and key populations compared to care workers receiving a constant salary b. To investigate whether the model is easily learned and scalable c. To explore whether the focused support to clients by the franchisees increased the number of clients linked to care d. To investigate whether the CBCT mobile data management system improved the monitoring and evaluation system 2. To determine the proportion of clients tested and linked to care through the SFHCT model during the period of evaluation 3. To qualitatively investigate the experiences, barriers and facilitators to optimal social franchise implementation
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SFHCT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2016
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80000
Actual target sample size (number of participants)
Recruitment status 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 Non-randomised 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 Social Franchise HIV counselling and testing or SFHCT One HIV test per client during the study period Two (2 years) The Social franchisees (SFs) will be paid R40 (US$3.20) per HIV test conducted including a basic package of services to each client tested which include condom distribution, screening for TB and STI and documenting the client. R100 (US$8) will be paid for every HIV positive client linked to care. SFs will test at least 100 people per month, finding 5 HIV positive individuals and successfully linking at least 4 of them to care. FPD will monitor program performance data, HIV testing and referral process activities of SFs through monthly, bi-monthly and quarterly reports, field visits and observations. Data collection will be collected on a wireless mobile app and uploaded onto the database. 20
Control Group FPDHCT One HIV test per client during the study period Two 2 (years) FPD employees will test clients as per their employment contract. They are remunerated monthly through a normal payroll with no targets as the SF have. They report to FPD management. Data collection will be collected on a wireless mobile app and uploaded onto the database. 20 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Social franchisees will be local employed, unemployed or small scale business entrepreneurs with at least 12 years of formal education and some basic post-secondary education experience. HIV test clients will be anyone who is not confirmed to be HIV positive and has not tested for HIV in the last 6 weeks SFs shall not be FPD employees. HIV test clients who are HIV positive or anyone who tested for HIV in the last 6 weeks 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 12 Month(s) 90 Year(s) Both
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 26/02/2018 FPD Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
173 Mary Road, Die Wilgers Tshwane 0184 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome No of people tested; No of people linked to care; use of the mobile app per client tested every 12 months
Secondary Outcome demographic characteristics of populations reached by SFHCT vs FPDHCT; proportion of clients linked to care through the SFHCT compared to those linked to care through FPDHCT; barriers, facilitators, challenges and experiences of SF 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tshwane District Sub-districts 1 Tshwane South Africa
Tshwane District Sub-district 2 Tshwane South Africa
Tshwane District Sub-district 3 Tshwane South Africa
Tshwane Sub-distrist 4 Tshwane South Africa
Tshwane District sub-district 6 Tshwane South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
PEPFAR USAID 100 Totius Street, Groenkloof Tshwane South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PEPFAR USAID 100 Totius Street, Groenkloof Tshwane South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Simukai Shamu shamuts@yahoo.com +27128169000 173 Mary Road, Die Wilgers
City Postal code Country Position/Affiliation
Tshwane South Africa Senior Researcher Foundation for Professional Development
Role Name Email Phone Street address
Scientific Enquiries Nkhensani Nkhwashu nkhensanin@foundation.co.za 0128169000 173 Mary Road, Die Wilgers
City Postal code Country Position/Affiliation
Tshwane South Africa Head of Cluster
Role Name Email Phone Street address
Public Enquiries Thato Farirai thatof@foundation.co.za 0128169000 173 Mary Road, Di Wilgers
City Postal code Country Position/Affiliation
Tshwane South Africa Head of Department at FPD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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