HIV Infections
Conditions
Keywords
Adolescence, Community-based accompaniment, Retention, Antiretroviral treatment, Social support, Mental health, Treatment support, Adherence
Brief summary
This study is an evaluation of an intervention (nicknamed "PASEO") that aims to facilitate the transition to adult HIV care for adolescents living with HIV in Lima, Peru. The intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support. The study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the PASEO intervention with regard to retention with viral load suppression as well as other indicators of well-being. The cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. The cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. Data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.
Interventions
BEHAVIORALPASEO
The intervention consists of community-based accompaniment intervention aimed at facilitating the transition to adult HIV care for adolescents living with HIV in Lima, Peru.The intervention includes the following activities: health systems navigation and accompaniment to clinic visits, monthly check-ins with an entry-level health worker, social support provided through peer support groups, education sessions, resolution of acute needs, and individualized adherence support.
Sponsors
Harvard University Faculty of Medicine
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 23 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent or young person living with HIV and aware of diagnosis * 14 to 21 years of age (may be increased to 23 to meet recruitment targets) * Currently taking or eligible for ART at a participating facility * Scheduled to transition to adult care or previous unsuccessful transition to adult care * Willing to participate regardless of the study arm to which they will be assigned * Able and willing to provide written informed consent
Exclusion criteria
* Living outside of Lima province * Participation in the PASEO pilot study * Current enrollment in another research study * Having any condition (social or medical) which the study team considers would make participation unsafe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful transition | 12 months | Number of people who experience death, loss to follow-up or unsuppressed viral load \>200 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV-related death or loss to follow-up | within 12 and 24 months | Time to HIV-related death or loss to follow-up |
| Clinic visit attendance | 12 and 24 months | Number of scheduled visits attended, among those retained |
| CD4 cell count | 12 and 24 months | Change in CD4 cell count from baseline |
| Self-efficacy | 6, 9, 12, 24 months | Change in self-efficacy (assessed using the NIH toolbox) from baseline |
| Transition readiness | 6, 9, 12, 24 months | Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline |
| Perceived social support | 6, 9, 12, 24 months | Change in social support (assessed using the NIH toolbox) from baseline |
| HIV-related stigma | 6, 9, 12, 24 months | Change in HIV-related stigma (assessed using an Abbreviated Berger HIV Stigma Scale: score range 21-84, higher score indicating greater levels of stigma) from baseline |
| Social Connectedness | 6, 9, 12, 24 months | Change in social connectedness (assessed using the Social Connectedness Scale: score range 20-120, higher score indicating greater sense of social connectedness and belongingness) from baseline |
| Sexual Behavior | 6, 9, 12, 24 months | Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline |
| ART Adherence | 6, 9, 12, 24 months | Change in percentage of days, during the last 30, during which at least one dose was missed (assessed using a 30 day-recall) from baseline. Minimum= -100, maximum=100; scores above 0 indicate an improvement relative to baseline, with higher scores indicating greater improvements. Assessed among those on treatment for at least a month at enrollment. |
Countries
Peru
Contacts
PRINCIPAL_INVESTIGATORMolly Franke, ScD
Harvard Medical School (HMS and HSDM)
Outcome results
None listed