Table 1.
Measures and source at baseline, 6 months, and 12 months.
| Constructs/measures | Instrument and specification | Source | Cohort | |
| Primary and secondary endpoints—HIV care continuum and HIV risk behavior | ||||
|
|
HIV testing: proportion tested for HIV in the past 6 and 12 mo | Abstraction tool (serologic HCTa) and self-report confirmed via clinic audit; repeat HCT at 6-month intervals will be assessed | Clinic audit, self-report | HIV-/ub; 6 mo and 12 mo |
|
|
HIV early detection: proportion with HIV identified through voluntary testing | All participants will be tested to determine HIV status (rapid finger prick and follow-up per Zambian guidelines) | Biological | HIV-/u; 12 mo |
|
|
Linkage to care: proportion enrolled at an HIV clinic in ≤30 days; ART initiated in ≤90 days | Measured as days from testing HIV positive or from baseline when not on treatment (HIV+ but not on ARTc) | Clinic audit | HIV-/u, HIV+d; 6 mo and 12 mo |
|
|
Retention in HIV care: proportion with at least one visit every 3 months | Prespecified abstraction tool to capture any HIV care–related visits over a 12-month period (clinic or dispensary visits) | Clinic audit | HIV+; 6 mo and 12 mo |
|
|
Adherence to ART: proportion filling prescriptions at least every 3 months | 3-month supply of ART medications recommended by Zambian guidelines | Clinic audit | HIV+; 6 mo and 12 mo |
|
|
Viral load suppression: proportion with undetectable viral load | HIV plasma viral load tests using the Roche platform | Biological | HIV+; 6 mo and 12 mo |
|
|
HIV risk behavior: proportion with delay in first intercourse, reduction in sexual partners, increases in condom use | Demographic and health survey and AGEPe instrument (measures will be based on previous studies by grant team, including AGEP) | Self-report | HIV-/u; baseline, 6 mo, and 12 mo |
| Mediating outcomes, SHIELDf intervention dose, and clinic-based services | ||||
|
|
Self-efficacy | Measurement scale developed and tested for the AGEP | Self-report | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Social support (AGYWg report on family and peer interaction) | Medical Outcomes Study instrument previously used in Zambia [38]; AGEP PNh and youth club feedback instrument | Self-report | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Mental health | Strengths and Difficulties Questionnaire, youth version [39] | Self-report | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
HIV stigma, gender-based violence | AGEP instrument | Self-report | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Unintended pregnancy | Tested at baseline and 12 mo | Urine test | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Education modules (AGYW and family) | Number of modules completed | Study database | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Youth club attendance | Number and proportion of meetings attended | Study database | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
Caregiver assessment | Parent Strengths and Difficulties Questionnaire and survey on AGYW support (to be developed) | Self-report | HIV-/u and HIV+; baseline, 6 mo, and 12 mo (unless otherwise specified) |
|
|
HPVi vaccination | Proportion receiving 1, 2, or 3 doses (IWCj clinic only) | Clinic audit | HIV-/u and HIV+; 6 mo and 12 mo |
|
|
Number of clinic visits | Proportion with visits at 6 mo and 12 mo; total number of visits | Clinic audit | HIV-/u and HIV+; 6 mo and 12 mo |
|
|
Sexual and reproductive health services provided | Family planning, sexually transmitted diseases, and condoms | Clinic audit | HIV-/u and HIV+; 6 mo and 12 mo |
| PNs and clinic staff feedback on AGYW HIV care | ||||
|
|
PNs | PN feedback instrument (to be developed) | Self-report | Baseline, 6 mo, and 12 mo |
|
|
Clinic staff attitudes and feedback | 10 staff interviewed at each clinic; modified Nyblade instrument | Self-report | Baseline, 6 mo, and 12 mo |
| Baseline data for AGYW | ||||
|
|
Demographics and socioeconomic status | AGEP baseline instrument | Self-report | All AGYW |
aHCT: HIV counseling and testing.
bHIV-/u: HIV-negative/unknown.
cART: antiretroviral therapy.
dHIV+: HIV-positive.
eAGEP: Adolescent Girl Empowerment Program.
fSHIELD: Support for HIV Integrated Education, Linkages to Care, and Destigmatization.
gAGYW: adolescent girls and young women.
hPN: peer navigator.
iHPV: human papillomavirus.
jIWC: integrated wellness care.