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.: PACTR202302702036850 Date of Approval: 18/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Financial incentives to improve uptake of partner notification for sexually transmitted infections in antenatal care in Zimbabwe
Official scientific title Financial incentives to improve uptake of partner notification for sexually transmitted infections in antenatal care in Zimbabwe
Brief summary describing the background and objectives of the trial Sexually transmitted infections (STIs) such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and syphilis, are associated with adverse birth outcomes. Provision of treatment, whether syndromic or aetiological, should be accompanied by counselling and effective partner notification (PN), to prevent re-infection and break cycles of transmission. However, in Southern Africa, uptake of PN and partner treatment are often very low. Alternative strategies to facilitate PN are therefore needed. The aim of this study is to assess the effect of a small financial incentive on improving PN for STIs within antenatal care (ANC) services in Zimbabwe.
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 Sexually transmitted infections
Purpose of the trial Financial incentive
Anticipated trial start date 23/01/2023
Actual trial start date 23/01/2023
Anticipated date of last follow up 23/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
26787 London School of Hygiene and Tropical Medicine
A.2899 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 Randomised Simple randomization using a randomization table created by a computer software program 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 Financial incentive $3 (USD) given to partners of index cases when they attend clinic for presumptive STI treatment One-off payment Pregnant women diagnosed with an STI within the main IPSAZ study will be counselled and given partner notification slips to give to their partners, who should return to the clinic for treatment. In the intervention arm, these partner notification slips will be associated with a $3 (USD) incentive, which the partner will recieve on attending clinic for treatment. Treatment will be provided free-of-charge. 150
Control Group Control No incentive associated with partner notification slip. One-off attendance for treatment Pregnant women diagnosed with an STI within the main IPSAZ study will be counselled and given partner notification slips to give to their partners, who should return to the clinic for treatment. In the control arm, these partner notification slips have no associated incentive. However, treatment will be provided free-of-charge. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women attending clinic for routine antenatal care 2. Diagnosed with a curable STI (chlamydia, gonorrhoea, trichomoniasis or syphilis) or treated for an STI syndrome, by the main IPSAZ study 3. Willing to take part in partner notification 1. Enrolment in this study on a previous antenatal care visit 2. Being unable or unwilling to provide written informed consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 65 Year(s) Female
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 10/12/2022 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road Harare 0 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
Yes 26/05/2022 London School of Hygiene and Tropical Medicine Interventions Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of index patients with at least one partner who returns to the study site for treatment within 28 days of diagnosing the index. 28 days after diagnosis of index case
Secondary Outcome The number of days between index case diagnosis and the partner attending for treatment 28 days after diagnosis of index case
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbare Polyclinic Third Avenue Harare Zimbabwe
Mabvuku Clinic Manresa Way Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Biomedical Research and Training Institute 10 Seagrave Road Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kevin Martin kevin.martin@lshtm.ac.uk +263777195185 Biomedical Research and Training Institute, 10 Seagrave Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Clinical research fellow
Role Name Email Phone Street address
Public Enquiries Kevin Martin kevin.martin@lshtm.ac.uk +263777195185 Biomedical Research and Training Institute, 10 Seagrave Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Clinical research fellow
Role Name Email Phone Street address
Scientific Enquiries Kevin Martin kevin.martin@lshtm.ac.uk +263777195185 Biomedical Research and Training Institute, 10 Seagrave Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Clinical research fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The informed consent procedure will clarify the sharing of anonymised data, either via a public data repository, or by directly sharing with other researchers. At the time of publication of research, the subset of data required for the purposes of verifying research findings will be made available for sharing and will be placed in Data Compass (the LSHTM institutional research data repository – accessible at https://datacompass.lshtm.ac.uk/). This repository will enable direct download of records with codebooks to enable replication of the data analyses. A more complete sharing of data with any research group requesting access to individual data records will be done 12 months after publication. At this point, all data and study tools will be made available through Data Compass. Data for sharing will be de-identified prior to release. Details of how to access data will be published with each study publication. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months If access to the data is requested for the purposes of re-analysis and publication, such access will only be granted if a Zimbabwean colleague is included in any resulting manuscripts as a collaborator and author. Data users will be required to acknowledge the source of data and to ensure that the regulatory requirements of the Medical Research Council of Zimbabwe (MRCZ) are met.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://datacompass.lshtm.ac.uk/ 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