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.: PACTR201810525630303 Date of Approval: 11/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HIV Self-testing and Linkage to Care among the Youth in Zambia
Official scientific title HIV Self-testing and Linkage to Care among the Youth in Zambia: A Demonstration Project Implemented by EQUIP
Brief summary describing the background and objectives of the trial Zambia’s national HIV prevalence stands at 13.3 % among reproductive age populations, and young adults aged 16-24 years constitute 33% of people living with HIV, and the account for close to half of new infections each year. In 2014, only 46% and 37% females and males respectively aged 15-24 years old knew their status.HIV self-testing has recently been adopted as a strategy in Zambia and local context evidence is needed to inform scale-up and wider adoption. As part of its rapid response to strengthen HIV prevention and treatment, EQUIP is implementing a demonstration project to evaluate the potential contribution of the HIV ST strategy to increased testing rates among youths and adolescents ( 16-24 years of age in 15 selected intervention clusters as compared to control clusters in two districts on the Copperbelt and Central provinces of Zambia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 05/06/2017
Actual trial start date 26/09/2017
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 30/07/2018
Anticipated target sample size (number of participants) 5280
Actual target sample size (number of participants) 5353
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 HIV Self test This was cluster randomized control. HIV Self test was conducted only in experimental sites while standard methods of HIV testing such as Provide Initiated counseling testing was used in the comparative sites This was once off. The main proposed intervention is primarily HIV ST for the adolescents and young adults who are in high school and colleges, as well as those out of school within the surrounding communities. The intervention is combined with social mobilization and communication methods, which include availability of toll free telephone and short messaging services (SMS) to allow for counselling and linkage to care. 15
Control Group Provide Initiated Counselling and testing Routine testing For the period of study ( 6 months) This was routine testing using Provider initiated counseling and testing 15 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. Persons aged 16 -24 years • Able and willing to provide written informed consent to HIV-ST (in intervention clusters); consent will be required from legal guardians for minors ages under 18 years of age, and written ascent from the participant • Accepts health volunteers/or peer educators • Resident within the catchment area or learning institution . Age below 16 years and over 24 years • Verbalized refusal to participate • Usual residence outside of the intervention cluster • Not willing to link into care after using the self test • Any evidence of inability to make responsible decisions for any reasons such as mental instability Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 24 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 08/05/2017 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road, Rhodes Park, Lusaka Lusaka 0000 Zambia
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 10/06/2017 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road, Rhodes Park, Lusaka Lusaka 0000 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV testing uptake At entry
Secondary Outcome HIV status At entry
Secondary Outcome Linkage to treatment and Care At entry or Follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kabwe District Kabwe Central Zambia
Ndola District Ndola Copperbelt Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID EQUIP USAID Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USAID Washington Washington United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Crispin Moyo crispin.moyo@equiphealth.org +260973313413 1105, Off Brentwood road, Mwikala House, Longacres
City Postal code Country Position/Affiliation
Lusaka Zambia Country DirectorRight to Care Zambia
Role Name Email Phone Street address
Public Enquiries Charles Chasela charles.chasela@equiphealth.org +27765240898 1006 Lenchen Avenue North, Centurion
City Postal code Country Position/Affiliation
Johannesburg South Africa Chief Scientific Officer Right to Care South Africa
Role Name Email Phone Street address
Scientific Enquiries Roma Chilengi Roma.Chilengi@cidrz.org +260973724935 1105, Off Brentwood road, Mwikala House, Longacres
City Postal code Country Position/Affiliation
Lusaka Zambia Project Coordinator
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