Trial Outcomes & Findings for Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana (NCT NCT03571555)

Results Overview

The 17 item Pediatric Symptom Checklist (PSY-Y-17) will be used. Minimum value 0, maximum 51. Higher scores, worse outcome.

Recruitment status

COMPLETED

Target enrollment

516 participants

Primary outcome timeframe

One year

Results posted on

2021-04-26

Participant Flow

Participants were not assigned to groups. The study was an uncontrolled cohort study.

Participant milestones

Participant milestones
Measure	Young People With Perinatally Acquired HIV Residential interventions (camps) and community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.	Caregivers of Young People With Perinatally Acquired HIV Community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.
Overall Study STARTED	252	263
Overall Study COMPLETED	177	195
Overall Study NOT COMPLETED	75	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young People With Perinatally Acquired HIV n=252 Participants Residential interventions (camps) and community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.	Caregivers of Young People With Perinatally Acquired HIV n=263 Participants Community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.	Total n=515 Participants Total of all reporting groups
Age, Customized	16 years n=252 Participants	43 years n=263 Participants	30 years n=515 Participants
Sex: Female, Male Female	129 Participants n=252 Participants	242 Participants n=263 Participants	371 Participants n=515 Participants
Sex: Female, Male Male	123 Participants n=252 Participants	21 Participants n=263 Participants	144 Participants n=515 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Botswana	252 Participants n=252 Participants	263 Participants n=263 Participants	515 Participants n=515 Participants

PRIMARY outcome

Timeframe: One year

Population: Young people with perinatally acquired HIV

The 17 item Pediatric Symptom Checklist (PSY-Y-17) will be used. Minimum value 0, maximum 51. Higher scores, worse outcome.

Outcome measures

Outcome measures
Measure	Young People With Perinatally Acquired HIV n=249 Participants Residential interventions (camps) and community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.	Caregivers of Young People With Perinatally Acquired HIV Community based support (clubs) Sentebale Psychosocial Programme: Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.
Quality of Life/Well-being (Young People)	4.77 score on a scale Standard Deviation 4.21	—

SECONDARY outcome

Timeframe: One year

The Brief HIV Knowledge Questionnaire (Carey \& Schroder, 2002) and other measures (Aaro et al, 2011; Evangeli et al, 2016) will be adapted to produce a new measure of general HIV knowledge, transmission, medication and reproduction information.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The 18 item Illness Cognition Questionnaire will be used (Evers et al., 2001).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the CASE adherence index (Mannheimer et al., 2006) will be used. Higher scores indicate higher self-reported ART adherence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of 15 item antiretroviral medication attitudes scale (Viswanathan, Anderson, \& Thomas, 2005) will be used. Higher scores indicate more positive adherence attitudes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the 12 item HIV medication self-efficacy scale (Erlen, Cha, Kim, Caruthers, \& Sereika, 2010) will be used. Higher scores indicated higher adherence self-efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The 18 item Adolescent HIV Disclosure Cognitions and Affect Scale (Evangeli, 2017) will be used to assess attitudes towards sharing one's status, normative disclosure beliefs, disclosure affect and disclosure self-efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The 18 item Adolescent HIV Disclosure Cognitions and Affect Scale (Evangeli, 2017) will be used to assess attitudes towards sharing one's status, normative disclosure beliefs, disclosure affect and disclosure self-efficacy. The total score will be used. Higher scores indicate more pro-disclosure beliefs. An additional item assessed the young person's intention to share their status with others over the next year will be added. HIV disclosure events will be assessed at baseline and follow-up through recording the frequency of new disclosures in last year (first hand or second hand) and the proportion in one's social network disclosed to (Serovich, Craft, \& Reed, 2012; Serovich, Craft, \& Yoon, 2007).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

HIV disclosure events will be assessed at baseline and follow-up through recording the frequency of new disclosures in last year (first hand or second hand) and the proportion in one's social network disclosed to (Serovich, Craft, \& Reed, 2012; Serovich, Craft, \& Yoon, 2007).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The frequency of HIV communication will be measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The Adolescent HIV Communication Belief Scale (Evangeli, in press) will be used. An additional item will assess intention to communicate about HIV.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The 10 item Rosenberg global self-esteem measure will be used (Rosenberg, 1965).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the 10 item Stigma Scale - Revised (Wright, Naar-King, Lam, Templin, \& Frey, 2007) will be used. Higher scores indicate more HIV stigma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the 11 item Child and Adolescent Social Support Scale (Malecki \& Demaray, 2002) will be used. Higher scores indicate greater social support

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the 5 item Botswana Adolescent Beliefs about the Future Scale will be used. Higher scores indicate greater hope.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The HIV-KQ-18 measure (Carey \& Schroder, 2002) will be adapted for use in Botswana

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The 15 item antiretroviral medication attitudes scale (Viswanathan et al., 2005) will be used. The measure will be adapted for use with Batswana caregivers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

The total score of the 9 item HIV Stigma Scale will be used (Kalichman et al., 2005). Higher scores indicate higher levels of HIV stigma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Most recent viral load in the six months before the baseline assessment and most recent viral load in the six months after the follow-up period, will be collected from participants' clinical records.

Outcome measures

Outcome data not reported

Adverse Events

Young People With Perinatally Acquired HIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caregivers of Young People With Perinatally Acquired HIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Evangeli

Royal Holloway University of London

Phone: 00447801543681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place