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.: PACTR201606001682364 Date of Approval: 13/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Enhanced STI/HIV Partner Notification in South Africa
Official scientific title Enhanced STI/HIV Partner Notification in South Africa
Brief summary describing the background and objectives of the trial There are 5.6 million people living with HIV in South Africa, more than any other country in the world. Among the most significant factors known to facilitate HIV transmission are sexually transmitted infections (STI). People who contract STI in high-HIV prevalence places, such as South Africa, are therefore among the highest risk populations for HIV infection in the world. Single session behavioural interventions are feasible, cost efficient, and have shown significant impact on risks for STI. Unfortunately, promising intervention effects are undermined by persistent STI in untreated sex partners. A critical step in preventing STI re-infection is thus identifying and treating the sex partners of individuals who are recently diagnosed with an STI. Partner notification and referral to STI services are essential to prevent re-infection of index patients, decrease the pool of infectious partners, and prevent HIV transmission. We propose testing a theory-based approach to HIV risk reduction with enhanced partner notification counselling tailored for STI clinic patients in South Africa. Our study will test whether the effects of risk reduction counselling on contracting subsequent STI are enhanced by building skills for index patients to self-notify their current and recent sex partners. In addition, mediation analyses will test the impact of partner notifications on intervention effects for STI outcomes.
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 Prevention
Anticipated trial start date 02/06/2014
Actual trial start date 02/06/2014
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 1050
Actual target sample size (number of participants) 1050
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
US National Institutes of Health under award number R01HD074560
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 Simple randomisation using a randomisation table created by computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard didactic information Once 20 minutes 20 minutes of STI and HIV education counselling delivered by counsellor to participant, one-to-one 350 Active-Treatment of Control Group
Experimental Group : Risk Reduction + Enhanced Partner Notification Communication Skills Intervention Once One hour Based on the adapted IMB model, we developed a risk reduction counselling intervention that integrates individual patient risk reduction skills building with communication skills to enhance partner notification. 350
Experimental Group Skills building Once One hour Based on the adapted IMB model, we developed a risk reduction counselling intervention that comprises individual patient risk reduction skills building 350
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patient diagnosed with an STI (including HIV) at a clinic in Cape Town Under 18 years of age or already enrolled in the trial 18 Year(s) 100 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 01/10/2013 Ethics Committee of the South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive, Tygerberg, Cape Town Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome STI incidence (measured by treatment seeking for STI from routine public health records) 12 months post enrollment
Secondary Outcome Partner notification (self reported) 2 weeks post baseline and 3, 6 and 9 months post baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Guguletu Clinic NY1 Street Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health under award number R01HD074560 9000 Rockville Pike Bethesda Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Seth Kalichman 406 Babbidge Road, Unit 1020 Storrs, Connecticut CT 06269-1020 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Catherine Mathews Francie van Zyl Drive Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Catherine Mathews cathy.mathews@mrc.ac.za +27219380454 P.O. Box 19070, Tygerberg
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Unit Director
Role Name Email Phone Street address
Principal Investigator Seth Kalichman seth.k@uconn.edu +1 860 486 4042 406 Babbidge Road, Unit 1020
City Postal code Country Position/Affiliation
Storrs CT 06269-1020 United States of America Professor
Role Name Email Phone Street address
Public Enquiries Catherine Mathews cathy.mathews@mrc.ac.za +27219380454 P.O. Box 19070, Tygerberg
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Unit director
Role Name Email Phone Street address
Scientific Enquiries Moira Kalichman Moira.Kalichman@chip.uconn.edu +1860-486-8702 406 Babbidge Road, Unit 1020
City Postal code Country Position/Affiliation
Storrs CT 06269-1020 United States of America Project manager
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information