HIV
Conditions
Keywords
HIV, Adolescent, Young Adult, Viral Load, Counseling, Costs and Cost Analysis
Brief summary
The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.
Detailed description
The randomized controlled trial (RCT) will evaluate the effect of the SEARCH Youth intervention on long-term HIV viral load suppression among HIV-infected adolescents/young adults. The study's intervention is based on the PRECEDE model of behavioral change that is targeted towards adolescent and young adult behavior. The study design is a cluster-randomized trial where the unit of randomization is the HIV clinic: 14 clinics randomized to the intervention and 14 to the optimized country standard of care (Differentiated ART care, standard clinic hours, routine VL monitoring, access to 2nd and 3rd line ART), balanced within country. The target enrollment for the intervention is approximately 2300 (50-100 adolescents/young adults with HIV in each clinic, plus family members, providers and others taking part in qualitative interviews). Community-tailored youth testing and linkage strategies for ART will be implemented to recruit youth for the SEARCH Youth combination intervention RCT. Strategies to reach youth at the highest risk of HIV infection will be implemented. Those individuals who test HIV-positive will be referred to the local clinic for HIV treatment services and, if they otherwise meet entry criteria, to the SEARCH Youth study for possible inclusion. The components of the SEARCH Youth intervention include: * Administration of life-stage assessment tool at the beginning of each visit that links to life-stage specific actions and puts subsequent medical discussions into an appropriate context * Structured choice clinic access which will provide a choice to schedule visits during or after routine clinic hours or in an alternate location, with some phone-only visits available between in-person visits * Rapid feedback of VL results, by phone or in person, aiming to be provided within 72 hours, to provide immediate feedback on HIV suppression and engage participants in their overall health * Provider e-collaboratives that comprises of chat groups using WhatsApp or similar secure messaging applications to solicit input about challenging cases using de-identified information Participants will take part in the study for at least 2 years. Some participants, family members, providers, HIV-negative youth and key informants will also take part in qualitative interview guides. Costs of the SEARCH Youth intervention will be evaluated to assess its efficiency and cost-effectiveness including as cost per participant, cost per additional participant with viral suppression and cost per DALY gained.
Interventions
* Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information
Sponsors
Study design
Intervention model description
Cluster-randomized trial
Eligibility
Inclusion criteria
* HIV infection diagnosed according to country testing guidelines * Age 15-24 years * Enrolled in care in a study clinic * Ability and willingness to provide informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of SEARCH Youth Intervention | 2 years | Percentage of study participants with virologic suppression (HIV RNA \<400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics) |
Countries
Kenya, Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Clinics SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers
SEARCH Youth combination intervention:
* Administration of life-stage assessment tool
* Structured choice clinic access
* Rapid feedback of VL results
* Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information
Information presented for participants included in primary analysis. | 785 |
| Control Clinics Optimized country standard of care.
Information presented for participants included in primary analysis. | 764 |
| Total | 1,549 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 13 |
| Overall Study | Outmigrated to non-study community | 98 | 106 |
| Overall Study | Transfered to non-study clinic | 32 | 48 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Control Clinics | Intervention Clinics |
|---|---|---|---|
| Age, Customized Median age | 21 years | 21 years | 21 years |
| Antiretroviral regimen at enrolment ABC-3TC-EFV | 23 Participants | 11 Participants | 12 Participants |
| Antiretroviral regimen at enrolment AZT-3TC-ATV/r | 26 Participants | 14 Participants | 12 Participants |
| Antiretroviral regimen at enrolment AZT-3TC-NVP | 75 Participants | 42 Participants | 33 Participants |
| Antiretroviral regimen at enrolment Other | 81 Participants | 42 Participants | 39 Participants |
| Antiretroviral regimen at enrolment TDF-3TC-ATV/r | 28 Participants | 18 Participants | 10 Participants |
| Antiretroviral regimen at enrolment TDF-3TC-DTG | 182 Participants | 101 Participants | 81 Participants |
| Antiretroviral regimen at enrolment TDF-3TC-EFV | 1118 Participants | 527 Participants | 591 Participants |
| Baseline care status Engaged - started treatment > 6 months before enrolment with HIV care visit within 6 months | 1026 Participants | 530 Participants | 496 Participants |
| Baseline care status Recently engaged - started treatment within 6 months of enrolment | 466 Participants | 214 Participants | 252 Participants |
| Baseline care status Re-engaging - started treatment > than 6 months before enrolment, no HIV care visit within 6 months | 55 Participants | 19 Participants | 36 Participants |
| Baseline viral load <400 copies per mL | 1147 Participants | 574 Participants | 573 Participants |
| Drinks alcohol | 231 Participants | 94 Participants | 137 Participants |
| Education (started or completed) At boarding school | 112 Participants | 56 Participants | 56 Participants |
| Education (started or completed) No school | 55 Participants | 24 Participants | 31 Participants |
| Education (started or completed) Primary school | 1032 Participants | 525 Participants | 507 Participants |
| Education (started or completed) Secondary school | 369 Participants | 175 Participants | 194 Participants |
| Education (started or completed) Tertiary school | 93 Participants | 40 Participants | 53 Participants |
| Employment status Employed | 591 Participants | 308 Participants | 283 Participants |
| Employment status In school | 320 Participants | 155 Participants | 165 Participants |
| Employment status Unemployed | 638 Participants | 301 Participants | 337 Participants |
| Marital status Divorced | 179 Participants | 89 Participants | 90 Participants |
| Marital status Married, monogamous | 633 Participants | 327 Participants | 306 Participants |
| Marital status Married, polygamous | 95 Participants | 51 Participants | 44 Participants |
| Marital status Single, never married | 633 Participants | 291 Participants | 342 Participants |
| Marital status Widowed | 9 Participants | 6 Participants | 3 Participants |
| Mobile | 439 Participants | 229 Participants | 210 Participants |
| Number of children 0 children | 653 Participants | 323 Participants | 330 Participants |
| Number of children 1 child | 485 Participants | 227 Participants | 258 Participants |
| Number of children 2 children | 260 Participants | 131 Participants | 129 Participants |
| Number of children 3-5 children | 115 Participants | 64 Participants | 51 Participants |
| Race/Ethnicity, Customized African/Black | 1549 Participants | 764 Participants | 785 Participants |
| Region of Enrollment Kenya | 893 participants | 440 participants | 453 participants |
| Region of Enrollment Uganda | 656 participants | 324 participants | 332 participants |
| Sex: Female, Male Female | 1248 Participants | 605 Participants | 643 Participants |
| Sex: Female, Male Male | 301 Participants | 159 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 1,012 | 13 / 976 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 48 / 1,012 | 13 / 976 |
Outcome results
Effectiveness of SEARCH Youth Intervention
Percentage of study participants with virologic suppression (HIV RNA \<400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)
Time frame: 2 years
Population: Study participants at year 2, excluding those who enrolled on/after Dec 1, 2019, transferred care, outmigrated, or withdrew.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Clinics | Effectiveness of SEARCH Youth Intervention | All | 88.2 % of participants |
| Intervention Clinics | Effectiveness of SEARCH Youth Intervention | Engaged | 90.9 % of participants |
| Intervention Clinics | Effectiveness of SEARCH Youth Intervention | Recently engaged | 80.1 % of participants |
| Intervention Clinics | Effectiveness of SEARCH Youth Intervention | Re-engaging | 84.8 % of participants |
| Control Clinics | Effectiveness of SEARCH Youth Intervention | Re-engaging | 53.2 % of participants |
| Control Clinics | Effectiveness of SEARCH Youth Intervention | All | 80.5 % of participants |
| Control Clinics | Effectiveness of SEARCH Youth Intervention | Recently engaged | 73.5 % of participants |
| Control Clinics | Effectiveness of SEARCH Youth Intervention | Engaged | 85.3 % of participants |