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.: PACTR201311000696101 Date of Approval: 05/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Study to Assess Retention in Trials
Official scientific title A Randomized trial to assess retention rate using mobile phones versus contact tracing, and characterize trends in HIV-1 prevalence and incidence in a ptential HIV vaccine efficacy population of fishing communites arounc Lake Victoria, Uganda
Brief summary describing the background and objectives of the trial Human efficacy data are always pivotal and a seies of human efficacy trials in a different population for different vaccine targets (blood, rectal or cervial mucosal) need to be done before eventual success is attained. Population in sub-Saharan Africa where HIV diversity is reatest and HIV prevalence and incidence are still quite high will prepare a major role in next HIV vaccine efficacy trials (either singly or as part of multisite trials). With many vaccine candidates currently under develop
Type of trial RCT
Acronym (If the trial has an acronym then please provide) STAR
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 16/08/2012
Actual trial start date 09/07/2012
Anticipated date of last follow up 31/03/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 662
Actual target sample size (number of participants) 662
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
TA.2011.40200.035 EDCTP
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 Permuted block randomisation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone reminders Before every scheduled visit - 1, 3, 6, 12, 18 months one reminder before very visit Participants called (audio remindr) or sent sms reminder 331
Control Group Physical contact reminders before every scheduled visit - 1, 3, 6, 12, 18 months one reminder before every visit Participants called (audio reminder or sent sms reminder 331 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Capable and willing to provide written informed consent (literacy not required) or assent if aged <18 yrs; not emancipated in addition parent/guardian consent 2. Resident/working in study community at least 3mnths prior enrollment; intending to continue for at least 12 mnths post enrollment 3.Possession of mobile phone or ready access Willing to give blood for HIV testing HIV uninfected; at risk of HIV infection defined by 1 of following: a. Reported recurrent STI or STI previous 3mnths b. Unprotected sexual intercourse more than 1 partner in past 3 mnths c. Sexual intercourse with commercial sex worker in past 3 mnths d.In discordant relationship (partner HIV infected) e. Willing to undergo HIV testing, counseling and receive HIV test results f. Able, willing to provide adequate locator information for tracking purposes, willing to be contacted by study staff g. Willing to complete interviewer administered questionnaires on risk factors 1. Not sexually active in past 3 months 2. Participatin in antoher interventional study (e.g. investigational product/behavioural intertion) that may reduce incidence 15 Year(s) 49 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 17/04/2012 UVRI Science and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe 259 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of retention 1, 3, 6, 12, and 18 months
Secondary Outcome HIV-1 incidence 1, 3, 6, 12, 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasenyi landing site Kasenyi lakeshore beach Entebbe 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP PO Box 93015 2509AA The Hague Netherlands
UVRI-IAVI HIV Vaccine Program Plot 51-59, Nakiwogo Road Entebbe 256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makarere University School of Public Health PO Box 7072 Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Dr Ali Ssetaala UVRI-IAVI HIV Vaccine Program, Plot 51-59 Nakiwogo Road Entebbe 256 Uganda
Dr Annet Nanvubya UVRI-IAVI HIV Vaccine Program, Plot 51-59 Nakiwogo Road Entebbe 256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noah Kiwanuka nkiwanuka@gmail.com +256 792 788036 School of Public Health, Makere Univ College of Health Sciences, PO Box 7072
City Postal code Country Position/Affiliation
Kampala 256 Uganda
Role Name Email Phone Street address
Public Enquiries Noah Kiwanuka nkiwanuka@musph.ac.ug +256-792-788036 School of Public Health, Makerere Univ College of Health Sciences
City Postal code Country Position/Affiliation
Kampala 256 Uganda
Role Name Email Phone Street address
Scientific Enquiries Ali Ssetaala assetaala@iavi.or.ug +256-782-863749 UVRI-IAVI HIV Vaccine Program, Plot 51-59 Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe 256 Uganda
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