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.: PACTR202310623752472 Date of Approval: 25/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Clinic-Based Patient-Led Human Papilloma-virus DNA Self-Sampling Among HIV-Infected Women in Uganda.
Official scientific title Effectiveness of Clinic-Based Patient-Led Human Papilloma-virus DNA Self-Sampling Among HIV-Infected Women in Uganda.
Brief summary describing the background and objectives of the trial In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV self-collected vaginal swabs. Therefore, we propose a study to determine the efficacy of clinic-based versus home-based HPV DNA self-sampling among HIV-infected women attending a rural HIV clinic in Uganda. We believe that a randomized, single-blinded trial would achieve this objective, and so we have chosen it to guide the study. Including a total of 382 participants from a rural HIV clinic, randomized into a ratio of 1:1 for clinic- and home-based HPV self-sampling, would allow us to appropriately ascertain the difference in the uptake of HPV self-sampling between the two arms. The Integrated Biorepository of H3 Africa Uganda Laboratory would be used as a reference laboratory for the HPV DNA ex-traction, typing, and sequencing. At baseline, modified Poisson regression models would be used to measure factors associated with the prevalence of HPV and uptake in both arms at baseline. We randomly selected and followed-up 150 HIV infected women who had taken HPV self-sampling at baseline ( 75 clinc-based and 75 home-based). Visual inspection under acetic acid (VIA), as a gold-standard test for CC to grade for CIN, would be performed at 0 and 6 months among a random sample of 75 women with a self-collected HPV sample in each group. The difference in uptake could be determined using the intention-to-treat analysis. The difference in the groups by each variable would be summarized as the standardized mean difference (i.e., the mean difference divided by the pooled standard deviation). The predictors of the time for which participants would continue with HPV self-sampling in both arms, recovery, and Cox proportional hazards regression would be used.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Humanpapilloma virus
Purpose of the trial Early detection /Screening
Anticipated trial start date 12/01/2022
Actual trial start date 23/03/2022
Anticipated date of last follow up 02/06/2023
Actual Last follow-up date 02/06/2023
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL https://www.mdpi.com/1660-4601/20/16/6613
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clinic based HPV self sampling approach Baseline (0 months) and 6 months follow-up. Baseline (0 months) and 6 months follow-up. The intervention group will receive health education, and education on sample collection, and the midwife will be present to coach/mentor the women during the HPV self-sample collection. The woman will self-collect the sample and will also receive a visual inspection under acetic acid (VIA), which is a conventional CC screening approach at the clinic. The women will then take the HPV sample to the laboratory for storage at the facility and will also receive reminder calls or text messages for their next screening appointment. Women in the intervention arm will often receive call or text message reminders to come to collect the next testing kit from the midwife at the clinic. 75
Control Group Home based HPV selfsampling Baseline (0 months) and 6 months follow-up. Baseline (0 months) and 6 months follow-up. The control group will receive a testing kit from the community linkages person (CLP)representative in the community who will also educate the women on sample collection. The information the CLP will give will be on sample collection only. The CLP will wait and take sample batches to the clinic for storage and, later, shipment to the laboratory. The women will also consent to come to the clinic to receive VIA services within a week. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study team approached and enrolled all HIV-infected women; • Not pregnant • Not in menstrual periods • Aged 25 to 49 years who have never been screened • Not screened within the last year (those who have screened for more than 1 year with normal results) • Have abnormal screening results • Attending the HIV clinic • Have provided informed consent to them to participate in the study. All women who were critically ill and declined to participate in the study were excluded. Adult: 19 Year-44 Year 25 Year(s) 49 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 12/01/2022 Makerere University School of Public Health Higher Degrees Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
New Mulago Hill Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Continuation rate for HPV self-sampling. 2 times at baseline- 0 months and 6-months follow up
Secondary Outcome Cost-effectiveness of clinic-based HPV self-sampling Estimated baseline uptake at 0 months and 6-months follow up to estimate uptake and costs.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Luweero district Hospital Kasana Kasana 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
HEARD PhD Scholarship University of KwaZulu Natal Durban 27 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of KwaZulu Natal University of KwaZulu Natal Durban 27 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Thembae Ginindza Ginindza@ukzn.ac.za 0027312604214 University of KwaZulu Natal
City Postal code Country Position/Affiliation
Durban 27 South Africa Main PhD Supervisor
Role Name Email Phone Street address
Scientific Enquiries Roy William Mayega rmayega@musph.ac.ug 00256772412455 Makerere University, School of Public Health
City Postal code Country Position/Affiliation
Kampala 256 Uganda PhD Co Supervisor
Role Name Email Phone Street address
Principal Investigator Agnes Nyabigambo anyabigambo@musph.ac.ug +256774135496 University of KwaZulu Natal / Makerere University School of Public Health
City Postal code Country Position/Affiliation
Kampala 256 Uganda PhD Student
Role Name Email Phone Street address
Public Enquiries Hellen Opolot uncstresearch@uncst.go.ug +256414705525 Uganda National Council of Science and Technology
City Postal code Country Position/Affiliation
Kampala 00256 Uganda Executive Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data requests for de-identified individual trial participant data can be submitted starting 9 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Makerere University, School of Public Health through the principal investigator, Agnes Nyabigambo, Email: anyabigambo@musph.ac.ug | Mobile Phone: +256774135496; and the BIOMEDICAL RESEARCH ETHICS ADMINISTRATION Research Office, Westville Campus, Govan Mbeki Building University of KwaZulu-Natal P/Bag X54001, Durban, 4000 KwaZulu-Natal, South Africa Tel.: +27-31-260-4769 Fax: +27-31-260-4609, Email: BREC@ukzn.ac.za. Informed Consent Form,Study Protocol Data requests for de-identified individual trial participant data can be submitted starting 9 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Makerere University, School of Public Health through the principal investigator, Agnes Nyabigambo, Email: anyabigambo@musph.ac.ug | Mobile Phone: +256774135496; and the BIOMEDICAL RESEARCH ETHICS ADMINISTRATION Research Office, Westville Campus, Govan Mbeki Building University of KwaZulu-Natal P/Bag X54001, Durban, 4000 KwaZulu-Natal, South Africa Tel.: +27-31-260-4769 Fax: +27-31-260-4609, Email: BREC@ukzn.ac.za. BREC@ukzn.ac.za
URL Results Available Results Summary Result Posting Date First Journal Publication Date
BREC@ukzn.ac.za Yes 13/10/2023 30/05/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.mdpi.com/1660-4601/20/16/6613
Changes to trial information