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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH131414 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Participants randomized to the control arm of the study will receive a modestly enhanced standard of care. Specifically, they will receive HIV transition information in the form of a paper brochure and/or a video link, and a package of supplies (i.e., a pillbox, a folder to store medical documents). Participants will undergo depression and substance use screening and will be referred as needed. | |
| Intervention arm | Experimental | Participants randomized to the intervention arm of the study will receive a modestly enhanced standard of care. Specifically, they will receive HIV transition information in the form of a paper brochure and/or a video link, and a package of supplies (i.e., a pillbox, a folder to store medical documents). Participants will undergo depression and substance use screening and will be referred as needed. Participants allocated to this group will also receive the PASEO intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PASEO | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unsuccessful transition | Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL | 12 months |
| Unsuccessful transition | Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-related death or loss to follow-up | Time to HIV-related death or loss to follow-up | within 12 and 24 months |
| Clinic visit attendance | Number of scheduled visits attended, among those retained |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly Franke, ScD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Arzobispo Loayza | Lima | Lima Province | Peru | |||
| Instituto Nacional de Salud del Nino |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 12 and 24 months |
| CD4 cell count | Change in CD4 cell count from baseline | 12 and 24 months |
| Self-efficacy | Change in self-efficacy (assessed using the NIH toolbox) from baseline | 6, 9, 12, 24 months |
| Transition readiness | Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline | 6, 9, 12, 24 months |
| Perceived social support | Change in social support (assessed using the NIH toolbox) from baseline | 6, 9, 12, 24 months |
| HIV-related stigma | 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 | 6, 9, 12, 24 months |
| Social Connectedness | 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 | 6, 9, 12, 24 months |
| Sexual Behavior | Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline | 6, 9, 12, 24 months |
| ART Adherence | 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. | 6, 9, 12, 24 months |
| Breña |
| Lima region |
| Peru |
| Hospital Nacional Daniel Alcides Carrión | Callao | Lima | Peru |
| Hospital Nacional Hipólito Unanue | Lima | Peru |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |