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.: PACTR201602001460157 Date of Approval: 06/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community versus Clinic-based Adherence Clubs
Official scientific title Community Versus Clinic-based ART Adherence Clubs to Enhance Patient Long-term Retention-in-Care
Brief summary describing the background and objectives of the trial Adherence clubs are groups of 25-30 patients stable on antiretroviral treatment (ART) who meet once every two months with club facilitators (counselors, and nurses on dates of blood draws) for a one hour session during which counseling is provided and ART medication distributed. Clinic-based adherence clubs implemented in Khayelitsha, South Africa have demonstrated that patients participating in clubs have reduced loss to follow up and lower risk of viral load rebound compared to stable patients receiving routine clinic-based care. Key questions remain as to whether the effectiveness of adherence clubs differs when based at the clinic compared to those based in the community. This is an unblinded randomized controlled trial of community-based versus clinic-based adherence clubs for patients who are stable on ART. The overall goal of this study is to evaluate whether, compared to clinic-based adherence clubs, community-based clubs result in improved patient outcomes and greater retention in care without compromising overall quality of patient medical care.
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 Other Interventions
Anticipated trial start date 01/02/2014
Actual trial start date 12/02/2014
Anticipated date of last follow up 31/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Randomised Stratified allocation by participant neighborhood Allocation codes were prepared by a person separate to that allocating and placed in a sealed opaque envelope. Participants then chose from among the envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community-based club Community based adherence clubs for stable antiretroviral treatment patients held ever 2 months 24 months Adherence clubs, were 25-30 stable HIV infected patients on antiretroviral treatment meet every other month for medication pickup facilitated by a n HIV counsellor, were conducted within the communities where participants resided 400
Control Group Clinic based adherence clubs Every other month 24 months Adherence clubs, were 25-30 stable HIV infected patients on antiretroviral treatment meet every other month for medication pickup facilitated by a n HIV counsellor, were conducted at the clinic where patients receive their treatment. 400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age greater than or equal to 18 years No change in antiretroviral regimen in the previous year Virally suppressed for at least 12 months (patients are considered virogically suppressed if their two most recent viral load results were less than 400 copies/ml, with no more than one result between 50 and 400 copies.) Currently on D4T containing regimen Currently pregnant, or intending to become pregnant within 6 months at the formation of the club Current comorbidity or chronic illness (diabetes, epilepsy, active TB, cancer, mental illness, or other disease which requires routine and frequent clinical management). Hypertension which requires treatment with on more than one antihypertensive drug 18 Year(s) 99 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 21/11/2013 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Ave Braamfontein, Johannesburg 2000 South Africa
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 29/11/2013 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Ave, Braamfontein 2000, Johannesburg, South Africa Johannesburg 2000 South Africa
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 29/11/2013 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Ave, Braamfontein 2000, Johannesburg, South Africa Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients retained in adherence club care and having HIV viral suppression 24 months
Secondary Outcome Proportion of patients who choose to stop adherence club participation and return to standard of care clinic based services 24 months
Secondary Outcome Proportion of patients with contra-indications for continuation of adherence club participation 24 months
Secondary Outcome Proportion of patients identified with new or previously undiagnosed medical conditions at their annual clinic-based medical visit 12 and 24 months
Secondary Outcome Uptake of routine services including family planning, cervical cancer screening and antenatal care 12 months 24 months
Secondary Outcome Acceptability of adherence clubs 12 months 24 months
Secondary Outcome All-cause mortality 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Witkoppen Health and Welfare Centre 105 William Nicol Drive Fourways, Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development 1300 Pennsylvania Ave NW Washington, DC 20523 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Witkoppen Health and Welfare Centre 105 William Nicol Drive Fourways, Johannesburg South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Johns Hopkins Bloomberg School of Public Health 615 N Wolfe St Baltimore 21205 United States of America
University of North Carolina Gillings School of Global Public Health 135 Dauer Dr Chapel Hill 27516 United States of America
University of Antwerp 2610 Wilrijk Antwerp Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Valerie Keyser valeriek@witkoppen.co.za +27 11 705 2438 105 William Nicol Dr
City Postal code Country Position/Affiliation
Fourways, Johanesburg South Africa Physician, Director of HIV
Role Name Email Phone Street address
Principal Investigator Valerie Keyser valeriek@witkoppen.co.za +27 11 705 2438 105 William Nicol Dr
City Postal code Country Position/Affiliation
Fourways, Johanesburg South Africa Physician, Director of HIV
Role Name Email Phone Street address
Public Enquiries Lillian Mutunga lillianm@witkoppen.co.za +27 11 705 2438 105 William Nicol Dr
City Postal code Country Position/Affiliation
Fourways, Johanesburg South Africa Research Programmes Manager
Role Name Email Phone Street address
Public Enquiries Lillian Mutunga lillianm@witkoppen.co.za +27 11 705 2438 105 William Nicol Dr
City Postal code Country Position/Affiliation
Fourways, Johanesburg South Africa Research Programmes Manager
Role Name Email Phone Street address
Scientific Enquiries Colleen Hanrahan chanrah1@jhu.edu +1 410 502 9289 615 N Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America Co-investigator/Johns Hopkins Bloomberg School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Colleen Hanrahan chanrah1@jhu.edu +1 410 502 9289 615 N Wolfe St
City Postal code Country Position/Affiliation
Baltimore 21205 United States of America Co-investigator/Johns Hopkins Bloomberg School of Public Health
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 Recruitment status 02/06/2017 Modified Open to recruitment: actively recruiting participants Closed to recruitment: follow up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 04/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 04/07/2018 pactr update Treatment: Other Other Interventions
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other intervention 04/07/2018 pactr update Other Interventions