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Table 1 Inclusion and exclusion criteria and the anticipated sample size of all the CombinADO study participants

From: The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial

Participant

Inclusion

Exclusion

Anticipated sample size

AYAHIV

HIV-positive, per medical records and confirmed by health facility staff

Age 10–24 years

Registered as a patient at the study site

Aware of HIV+ status

Provision of signed and dated informed consent form for adolescents aged 18 and above

For adolescents aged 12–17, informed assent and parental informed consent to participate in the study

For adolescents aged 10–11, parental consent to participate in the study

Stated willingness to comply with all study procedures

Has an acute medical condition requiring immediate medical care

N = a minimum of 1200 and a maximum of 2400 for the post-intervention assessment

N = a minimum of 360 and a maximum of 720 exit interviews

Caregivers

Age 18 years and older

Attending a caregiver-specific support group

Willingness to be audio-recorded

None

N = a minimum of 90 and a maximum of 120 semi-structured interviews

HCW

Age 18 years and older

Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites

Willingness to be audio-recorded

None

N = a minimum of 70 and a maximum of up to 112 semi-structured interviews

N = a minimum of 35 and a maximum of up to 50 costing questionnaires

KI

Age 18 years and older

Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites

Willingness to be audio-recorded

None

N = a minimum of 32 and a maximum of 60 semi-structured interviews