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.: PACTR201605001602542 Date of Approval: 24/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nigeria PrEP Demonstration Study
Official scientific title A Demonstration Project of Antiretroviral-based HIV-1 Prevention Among High-risk HIV-1 Serodiscordant Couples in Nigeria
Brief summary describing the background and objectives of the trial The PrEP strategy supplies a drug that, taken regularly by an uninfected person, reduces the probability of becoming infected on exposure to the HIV-1 virus. This study explores how to implement the strategies in a large population as part of a comprehensive public health program aimed at preventing HIV infection. What are the barriers to uptake; why would people hesitate to adopt a prevention strategy? What are the barriers to adherence; what would prevent a person who has started PrEP or ART from continuing it? What are the most cost-effective ways of delivering, not just the drugs, but the counseling and support needed to make the strategies work? Should there be a separate program? Is it better done within an established program? If this demonstration project is successful, we will have in hand, a practical plan for the establishment of a comprehensive national program to prevent HIV infection in Nigeria with PrEP included in the national HIV prevention package. The target population for the demonstration project will be heterosexual serodiscordant couples. To start, a sample with a size of 600 heterosexual HIV-1 serodiscordant couples will be recruited for the study. PrEP would be administered through three sites selected from three States in Nigeria ¿ AnambThe project will have three primary goals: ¿ Construct a model that effectively delivers PrEP to serodiscordant couples. Within the context of this goal, the measure of effectiveness will be the number of new infections averted. ¿ Measure the cost effectiveness of the model. The measure of cost effectiveness will be cost per life-year gained and cost per infection averted ¿ Estimate what would be needed to scale up the delivery model to the national level. ra, Cross River and Plateau.
Type of trial CCT
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 30/11/2015
Actual trial start date 15/10/2015
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Truvada one tablet daily 18 months 600
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For heterosexual couples: 1). Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months) 2). Willing to enter the study as a couple and intending to remain as a couple for the next 12 months 3). Has not been on PrEP medication prior to enrollment in study For HIV-1 uninfected members of the couple (partner participants): 1). Able and willing to provide written informed consent 2). HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrolment visit 3).Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ¿60 mL/min 4). Not currently pregnant or breastfeeding 5).Not currently enrolled in an HIV-1 prevention clinical trial 6). Not currently using PrEP 7). Enrolment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator For HIV-1 infected members of the couple (index participants): 1) Able and willing to provide written informed consent 2). HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm 3). No history of WHO stage III or IV conditions 4). Not currently using ART 5). Currently using ART but viral load still higher than 5,000 copies/ml 6). Not currently enrolled in an HIV-1 treatment study. 7). Current pregnancy or breastfeeding do not disqualify a candidate who is infected. 1. Currently on ART and virally suppressed 18 Year(s) 55 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 15/05/2014 Nigerian Institute of Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
6 Edmund Crescent, Yaba - Lagos Lagos 00000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. data and assessments about the factors that support or create barriers to clients' use of PrEP and partner's use of TasP Last 12 months of the study
Primary Outcome 2. data and assessments about serodiscordant couples¿ attitudes towards ART and PrEP as for preventing HIV-1 transmission Last 12 months of the study
Primary Outcome 3. data on PrEP adherence; this will be in the form of clinic-based pill counts at follow-up visits and MEMS cap data on how frequently the pill bottle was opened. Every three months throughout the follow-up period
Primary Outcome 4. reduction in rate of use of condom per couple on PrEP; and rate of increase in STI diagnosed per couple on PrEP. This data will be generated from the clinical data and the behaviour surveillance data At the end of the study
Primary Outcome 5. an estimate of the prevalence of ART resistance that developed in patients who seroconverted while using PrEP. At the end of the study
Primary Outcome 6. an estimate of cost per life year gained and cost per infection averted for female sex workers and men who have sex with men At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital JUTH Jos 00000 Nigeria
Federal Medical Centre Calabar Calabar Calabar 00000 Nigeria
Nnambi Azikiwe Univerity Teaching Hospital NAUTH Nnewi 00000 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 440 5th Ave N Seattle WA 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Agency for the Control of AIDS Plot 823, Ralph Shodeinde Street, Central Area, Abuja, Nigeria Abuja 900211 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
FHI360/SIDHAS project UCTH. Calabar Calabar 00000 Nigeria
University of Jos Teaching Hospital UniJos Jos 00000 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Idoko jonidoko@yahoo.com +2348033215967 Plot 823 Ralph Shodeinde Street
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Director General, National Agency for the Control of AIDS
Role Name Email Phone Street address
Public Enquiries James Anenih anenihj15@yahoo.com +2348074637339 Plot 823 Ralph Shodeinde Street
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Study Administrator
Role Name Email Phone Street address
Scientific Enquiries Morenike Ukpong toyinukpong@yahoo.co.uk +2347062920394 Plot 823 Ralph Shodeinde Street
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Co-Principal Investigator
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information