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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010553581622 Date of Registration: 26/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of clinical and psychosocial outcomes after a life skills intervention among older adolescents transitioning to adult care.
Official scientific title Evaluating the provision of clinical and psychosocial outcomes after life-skills provision among perinatally infected adolescents receiving care at Mbagathii Hospital comprehensive care centre li
Brief summary describing the background and objectives of the trial In addition to dealing with chronic illness, HIV-infected adolescents have to confront psychosocial issues, maintain adherence to drugs, and learn to negotiate sexual relationships while undergoing rapid physical and psychological changes (UNAIDS, 2016) (Mueller et al., 2011b), (Agwu & Fairlie, 2013). Adolescents often demonstrate poor virological suppression (1-4,) which results in mortality. The primary and most frequent cause for this increased mortality is poor adherence ( (Lima et al., 2008), (Bygrave et al., 2012), (Mwau et al., 2018), (Nachega et al., 2009), .)(Koech et al., 2014), (Nglazi et al., 2012a), (Lamb et al., 2014), (Ngeno et al., 2019) to antiretroviral therapy. Transition into adult care requires all adolescents to be adept in navigating health systems and be self- motivated towards their care. Many interventions are created and developed by health workers and stakeholders and rarely meaningfully engage the beneficiaries; in this case, adolescents. This is besides evidence that a participatory program design for adolescents and young people are more beneficial. This study incorporates adolescents’ insights into the modification of the life-skills curriculum to contextualize it to their needs. F This study proposed to contribute to the knowledge gap in feasibility, acceptability and effectiveness of life-skills provision to HIV positive adolescents while using the socio-cognitive framework to observe the role of self-efficacy. The study will achieve this by piloting a modified Baylor’s life-skills curriculum as a psychosocial intervention among older adolescents who are in preparation for transition to adult care. The study's main objective is to determine the effect of life-skills building on clinical and psychosocial outcomes among perinatally infected adolescents. The primary outcome is ART adherence self-efficacy and secondary outcomes are self-esteem and viral load.
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 Psychosocial
Anticipated trial start date 22/10/2018
Actual trial start date 23/12/2018
Anticipated date of last follow up 23/08/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 77
Recruitment status Active, not 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
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 Adopted Baylors life skills curriculum The curriculum was offered through four sessions, each lasting three hours’ duration. It included topics such as sexuality, HIV knowledge, coping with stigma, pregnancy avoidance and contraception and Adherence to ART and self-care. The sessions were moderated by the PI and older HIV positive youth (young adults). The engagements had an interactive instruction approach through various platforms, including short movies, face to face instruction as well as a focus group approach to discuss responses and application of skills learnt in everyday life. weekly session for four weeks It included topics such as sexuality, HIV knowledge, coping with stigma, pregnancy avoidance and contraception and Adherence to ART and self-care. The sessions were moderated by the PI and older HIV positive youth (young adults). The engagements had an interactive instruction approach through various platforms, including short movies, face to face instruction as well as a focus group approach to discuss responses and application of skills learnt in everyday life. 42
Control Group standard of care No baylors curriculum lifeskills offered 12 weeks Standard of care which includes ART drug refills and counselling sessions for adolescents with poor adherence as identified from viral load results . It also includes unstructured support groups conducted once in three months. 40 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following was the inclusion criteria for enrolment into the study: - 1) HIV- infected adolescents aged 16-19 years of age accessing HIV care services with 2) More than three years’ duration of enrolment into HIV care at Mbagathi before transfer in and /or more than three years of ART use) and proven Perinatal infection either through documented HIV DNA polymerase chain reaction (PCR) results or a documented antibody test in childhood. 1. HIV positive adolescents ages 16-19 with documented sexual transmission of HIV 2. HIV positive adolescents ages 16-19 in whom disclosure is not started or was on-going 3. HIV positive adolescents ages 16-19 with perinatal infection who are currently experiencing WHO stage four disease manifestations. 4. HIV positive adolescents ages 16-19 with perinatal infection who do not give assent/consent to study participation 5. HIV positive adolescents with perinatal infection who have not commenced ART or have been initiated on ART less than six months at the time of study enrolment. 6. HIV positive adolescents ages 16-17 whose guardians decline to give consent Adolescent: 13 Year(s)-17 Year(s) 16 Year(s) 19 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 19/10/2018 Kenyatta National hospital University of Nairobi ethical committee
Ethics Committee Address
Street address City Postal code Country
college of health sciences Nairobi 19676 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence ART self efficacy 12 weeks
Secondary Outcome Self-esteem 12 weeks
Secondary Outcome Viral load 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbagathi referral hospital Mbagathi way Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health 31 Center Drive, MSC 2220, Bethesda, MD 20892-2220 USA Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fogarty International Center AT THE NATIONAL INSTITUTES OF HEALTH 31 Center Drive, MSC 2220, Maryland United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nyawira Gitahi gnyawira@gmail.com +254722387231 Mbagathi way
City Postal code Country Position/Affiliation
Nairobi Kenya PhD fellow
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Bukusi ebukusi@kemri.org +254733617503 Mbagathi way
City Postal code Country Position/Affiliation
Nairobi Kenya Chief research scientist KEMRI
Role Name Email Phone Street address
Public Enquiries Nyawira Gitahi gnyawira@gmail.com +254722387231 Magadi road
City Postal code Country Position/Affiliation
Nairobi Kenya KEMRI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant sharing will be done within 12 months of trial completion Clinical Study Report,Informed Consent Form 12 months Open data analysis will be permitted and availability of study data in a repository
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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