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: www.pactr.org
Trial no.: PACTR201710002651160 Date of Approval: 29/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title What are key barriers, enablers and motivators associated with starting PrEP, adhering to PrEP, and continuing PrEP
Official scientific title Providing PrEP in the public sector: A qualitative study exploring the perspectives on client uptake, adherence, and continuation of PrEP
Brief summary describing the background and objectives of the trial Although highly effective treatment options are becoming increasingly accessible in Zimbabwe, preventing new infections remains a critical priority. It is estimated that 32,000 new HIV infections occurred among adults in Zimbabwe in 2016.1 In an effort to enhance current HIV prevention programs, Zimbabwe¿s Ministry of Health and Child Care (MoHCC) included a provision in the 2016 National Guidelines for Antiretroviral Therapy for the Prevention and Treatment of HIV to allow oral pre-exposure prophylaxis (PrEP) as a part of a comprehensive HIV prevention package in the public sector.2 Beginning in July 2017, provision of oral PrEP will be piloted in two public sector facilities. An evaluation is being planned to understand the facility level challenges and successes of providing PrEP, and this protocol proposes a complementary study to better understand client experiences in this pilot. This study will use qualitative, in-depth interviews with several sub-populations of clients, categorized based on their uptake of PrEP and adherence to the PrEP appointment schedule. While at the facility, clients will be consulted regarding their willingness to be contacted for an interview by health workers. Those that agree will be contacted for an off-site follow-up interview.
Type of trial CCT
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 Prevention
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MRCZ-A-2234 Medical Research Council of Zimbabwe
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PrEP 1 pill a day As long as they want Following up clients who have taken up and not taken up PrEP 150
Control Group Those who decline PrEP none unspecified The intervention group will take PrEP and the control group will have declined to use PrEP. 150 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV negative Willing to take up PrEP HIV positive Renal failure 10 Year(s) 150 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 29/09/2017 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara / Mazowe St. Harare 0000 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 03/09/2018 Chesapeake
Ethics Committee Address
Street address City Postal code Country
6940 Columbia Gateway Dr #110 Columbia, MD 21046 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Perspectives on acceptance Approximately one week after declining PrEP or, after first scheduled appointment date for those that accepted PrEP.
Primary Outcome Challenges with attendance Interviews will occur approximately one week after the date of the first scheduled visit and the process will be repeated after the date of the second scheduled visit
Primary Outcome Challenges with adhering to PrEP Interviews will occur approximately one week after the date of the first scheduled visit and the process will be repeated after the date of the second scheduled visit
Primary Outcome Risk compensation Interviews will occur approximately one week after the date of the first scheduled visit and the process will be repeated after the date of the second scheduled visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ZNFPC Ngorima Youth Centre Ngorima Village, Rural Rusitu Chimanimani 0000 Zimbabwe
ZNFPC Spilhaus Clinic Harare Hospital Grounds P.O. Box 220 Southerton Harare 0000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development Abercrombie House, Eaglesham Road East Kilbride G75 8EA United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Clinton Health Access Initiative Block 4, Arundel Office Park, 107 Norfolk Avenue Harare 0000 Zimbabwe Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health and Child Care Kaguvi Building, Central Avenue Harare 0000 Zimbabwe
Mother and Child Health Integrated Programme Suite 1 and 2, House East,. Westgate Complex Harare 0000 Zimbabwe
UNICEF 6 Fairbridge Avenue, Belgravia Harare 0000 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alec Mkwamba amkwamba@clintonhealthaccess.org +263785701786 Block 4, Arundel Office Park
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Senior Evaluation Manager
Role Name Email Phone Street address
Public Enquiries Makaita Makaita mgombe@clintonhealthaccess.org +263774305424 Block 4, Arundel Office Park
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Senior Evaluation Coordinator
Role Name Email Phone Street address
Scientific Enquiries Alec Mkwamba amkwamba@clintonhealthaccess.org +263785701786 Block 4, Arundel Office Park
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Senior Evaluation Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 16/10/2017 edit 1650 300
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/10/2017 Incompletely completed before Depart Department for International Development
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 11/10/2017 Had omitted the control group 150 1650
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 11/10/2017 Had omitted the control group 150 300
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable