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.: PACTR202006754762723 Date registered: 04/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EMPOWER: An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girls and young women in South Africa and Tanzania
Official scientific title EMPOWER: An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girls and young women in South Africa and Tanzania
Brief summary describing the background and objectives of the trial This is a multi-site prospective implementation science study to assess the feasibility, acceptability and safety of offering oral PrEP as part of a combination prevention package that addresses Gender-based violence (GBV), stigma and HIV in Adolescent Girls and Young Women (AGYW) at substantial risk for HIV infection aged 16-24 years in two demonstration sites (South Africa and Tanzania). In Part I of the study, participants who consent for screening will be counselled and tested for HIV and asked about experiences of GBV and stigma. Those that test positive for HIV will be linked to care. Those that report current experiences of violence or stigma and that are at immediate risk of danger will be linked to care. In Part II of the study, HIV negative participants will be invited to consent to enrol in a prospective cohort and followed up for a maximum of 15 months. Participants will be provided with information regarding their HIV risk and prevention options, including oral PrEP. Those that are interested in using PrEP will be assessed for eligibility. Up to 500 PrEP acceptors will be enrolled in the study. Participants who initially decline PrEP at enrolment have the option to accept PrEP during the first 6 months of the study until accrual is complete. Participants who accept oral PrEP will be randomised in a 1:1 ratio to receive standard adherence support (counselling and SMS support) or enhanced adherence support which includes allocation to adherence support clubs that will offer a four-session empowerment intervention in addition to the standard adherence support. Randomization will be stratified by site to ensure balance. All participants will followed up quarterly for a maximum of 15 months. Three community dialogues will be implemented during the follow-up period to promote social support for positive social norms around gender and HIV prevention. A subset of participants (n=50), health care providers (n=20) and community stake-holders (n=20) will be recruited to participate in serial qualitative interviews as part of a process evaluation to assess the implementation of the intervention and the acceptability and feasibility of the intervention from different perspectives
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EMPOWER
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 31/03/2016
Actual trial start date 01/09/2016
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date 30/03/2018
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 431
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
4353 SANCTR
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 randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PrEP Per protocol all eligible participants will be offered once daily oral PrEP (Truvada ) - oral emtricitabine 200mg/tenofovir disoproxil fumerate 300mg (FTC/TDF) as part of the combination HIV prevention package HIV negative participants invited to enrol will be followed up for a maximum of 15 months To assess whether it is feasable, acceptable and safe to offer oral PrEP as part of a combination HIV prevention package that addresses GBV, stigma and HIV in AGYW aged 16 - 24 years in two sites. ( South and Tanzania). This study will enrol up to 500 PrEP acceptors in the study. Participants who initially decline PrEP at enrolment have the option to accept PrEP during the first six months of the study until accrual is complete. The study is an open-label study whereby all enrolled participants will be offered oral PrEP as part of the combination prevention package. Within the cohort of women receiving oral PrEP participants will be randomly assigned to receive standard adherence support only or be invited to participate in EMPOWER clubs in addition to the standard adherence support. 500
Control Group PrEP All participants will be offered once daily oral emtricitabine 200mg/tenofovir disoproxil fumerate 300mg (FTC/TDF) as part of a combination HIV prevention package HIV negative participants invited to enrol will be followed up for a maximum of 15 months Participants who accept oral PrEP will be randomised in a 1:1 ratio to receive standard adherence support (counselling and SMS support) compared to enhanced adherence support which includes allocation to adherence support clubs that will offer a four-session empowerment intervention in addition to the standard adherence support 500 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. AGYW (born female) at substantial risk for HIV infection who are confirmed age 16 - 24 years ( inclusive) 2. HIV seronegative 3. Interested in HIV prevention methods, including oral PrEP 4. Sexually active per participant report, defined as having vaginal intercourse at least once in the past 30 days 5. Willing and able to provide adequate locator information and 6. Willing and able to provide informed consent or assent ( if parental consent is required per local regulations) and 7. Regular access to mobile phone with SMS capability Not planning to be in the study area during the follow-up period or has obligations that would require long absences (>8 weeks at a time) from the study area; •HIV seropositive; •Women identified at screening as being at immediate risk of harm (either from self or others); •Signs or symptoms of acute HIV infection; •Currently pregnant; •Renal dysfunction (creatinine clearance <60ml/min, Schwartz equation); •Receiving on-going therapy with agents with substantial nephrotoxic potential; or •Hepatitis B seropositive. •Currently enrolled or planning to enrol in another HIV prevention research study; •Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial; or •Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 24 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 05/08/2016 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of the Witwatersrand Medical School - Faculty of the Health Sciences, Phillip Tobias Building, Office 301, 3rd Floor 29 Princess of Wales Terrace Corner York Parktown Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Key primary outcomes For part I, the main outcomes of interest are •The proportion of AGYW who accept HIV counselling and testing with clinical enquiry for GBV/stigma out of the total number offered at (1) programme entry, and (2) over 12-15 months of follow-up; •The proportion of AGYW who report experience of GBV/stigma at (1) programme entry, and (2) over 12-15 months of follow-up; •The proportion of those who report GBV/stigma who accept referral to other services, including HIV treatment; •Proportion of providers who continue to offer HCT with integrated GBV/stigma clinical enquiry at 12 months; •Participant, provider and community stake-holder reported satisfaction with services (qualitative and quantitative data) For part II, we will assess •the proportion of AGYW who accept PrEP at enrolment, and overall; •time to PrEP initiation •attendance at adherence clubs •proportion of AGYW retained in care at scheduled follow-up visits, overall and by adherence intervention arm •the proportion of AGYW with detectable TFV levels at 3 and 6 months, overall and by adherence intervention •proportion of participants reporting GBV and/or stigma over 15 months of follow-up overall, by site and by adherence intervention •frequency of grade 2, 3, 4 clinical and laboratory events •empowerment scores among AGYW, overall and by adherence intervention •Participant, provider and community stake-holder reported satisfaction with services (qualitative and quantitative data) 1,3,6,9,12,15
Secondary Outcome Key secondary outcomes: Correlates of GBV and stigma, and factors associated with linkage-to-care for GBV; •Correlates of PrEP acceptance and time to first acceptance; •Correlates of PrEP adherence and continuation; •Correlated of AGYW self-efficacy, empowerment, and influence on relationship dynamics (including partnership harmony, perceptions of couple communication and fidelity; reported intimacy and partner testing; •Change in HIV prevention and risk behaviours among PrEP users and non-users over time; •Frequency of antiretroviral drug resistance among women who acquire HIV infection; •Costs and cost-effectiveness of the combination package and each of its elements; •Correlates of contraceptive use and pregnancy incidence; •To explore through qualitative and quantitative assessments whether this combination package leads to improvements in quality of care for GBV and HIV. 1,3,6,9,12,15
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wits RHI Ward 21 Clinical Research Site Wits RHI Ward 21 Clinical Research Site, 2nd floor, Ward 21, Hillbrow Health Precinct, 22 Esselen Street, Hillbrow, Johannesburg. Johannesburg 2001 South Africa
Mwanza Intervention Trials Unit MITU, Isamilo Street Mwanza City Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Evidence for HIV Prevention in Southern Africa EHPSA Offices Lady Brooks Building No 14, 12th Street Justice Mohamed and Brooklyn Streets Menlo Park Pretoria Pretoria 0181 South Africa
Medical Research Council South Africa Francie van Zijl Drive Parowvallei Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wits Health Consortium 31 Princess of Wales Terrace, Parktown, Johannesburg Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
International Center for Research on Women 1120 20th St NW Suite 500 North Washington, D.C. Washington 20036 United States of America
Mwanza Intervention Trials Unit National Insitute for Medical Research Mwanza Centre Isamilo Road, Mwanza Mwanza United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sinead Delany Moretlwe sdelany@wrhi.ac.za +27113585300 Wits RHI, 22 Esselen Street, Hillbrow, Johannesburg
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa Director Research
Role Name Email Phone Street address
Public Enquiries Sinead Delany Moretlwe sdelany@wrhi.ac.za +27113585300 Wits RHI, 22 Esselen Street, Hillbrow, Johannesburg
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa Director Research
Role Name Email Phone Street address
Scientific Enquiries Sinead Delany Moretlwe sdelany@wrhi.ac.za +27113585300 Wits RHI, 22 Esselen Street, Hillbrow, Johannesburg
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa Director Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data after all patient identifiers have been removed. Study Protocol The IPD will be shared once the study is completed, analyses are done and article with main study findings published. The PI will share the data if requested and the request is consistent with research ethics and the university IRB rules.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 28/05/2020 We were not aware that an IPD Sharing Statement was required for registration. We have amended our application to reflect this new information. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 28/05/2020 We were not aware that an IPD Sharing Statement was required for registration. We have amended our application to reflect this new information. Individual participant data after all patient identifiers have been removed.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 28/05/2020 We were not aware that an IPD Sharing Statement was required for registration. We have amended our application to reflect this new information. The IPD will be shared once the study is completed, analyses are done and article with main study findings published.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 28/05/2020 We were not aware that an IPD Sharing Statement was required for registration. We have amended our application to reflect this new information. The PI will share the data if requested and the request is consistent with research ethics and the university IRB rules.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 28/05/2020 We were not aware that an IPD Sharing Statement was required for registration. We have amended our application to reflect this new information. Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 29/05/2020 An error was made in the entering of information for the application, as the MITU site was overlooked. We have now added the missing information. Mwanza Intervention Trials Unit, MITU, Isamilo Street, Mwanza City, , Tanzania