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Table 1 Outcome definitions for the Indian National Collaboration on AIDS (NCA) study

From: Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India

 

Outcome

Data inputs

Population (denominator)

Definition

Primary Outcome

 HIV testing

1

HIV testing in the prior 12 moths

Survey

All participants, excluding those that report being HIV-positive AND report being tested more than 12 months ago.

Either 1 OR 2:

1. Reports HIV test within the prior 12 months

OR

2. Was told he/she had HIV within the last 12 months

Secondary Outcomes

 Awareness of HIV status, access to care, and HIV treatment

2

Awareness of HIV status among HIV-seropositive persons

1. Survey

2. Serologic HIV test

HIV seropositive participants

Reports having a positive HIV test OR being told by a doctor that he/she had HIV.

3

Accessing HIV medical care in prior 6 months

1. Survey

2. Serologic HIV test

HIV seropositive participants

Reports seeing a doctor about HIV AND reports visit with the indicated doctor in the prior 6 months.

4

Use of ART among ART-eligible

1. Survey

2. Serologic HIV test

HIV seropositive participants who meet either criteria 1 or 2

1. Reports taking ART at any time in the past

OR

2. CD4 < 350 cells/μL

Reports ART use in prior 30 days.

5

Use of trimethoprim-sulfamethoxazole (TMP-SMX) when indicated

1. Survey

2. Serologic HIV test

3. CD4

HIV seropositive AND CD4 count < 200 cells/μL

Reports taking TMP-SMX in past 30 days

6

Viral suppression among ART-eligible

1. Survey

2.Serologic HIV test

3. CD4

4. HIV RNA

HIV seropositive participants who meet either criteria 1 or 2

1. Reports taking ART at any time in the past

OR

2. CD4 < 350 cells/μL

HIV RNA <150 c/mL

7

Viral suppression among HIV-positive

1. Serologic HIV test

2. HIV RNA

HIV seropositive participants

HIV RNA <150 c/mL

8

Average CD4 cell count among HIV-positive

1. Serologic HIV test

2. CD4 cell count

HIV seropositive participants

CD4 cell count

 Risk behaviors, substance use, and depression

9

Unprotected anal intercourse with non-main male partner in prior 6 months [MSM]

Survey

Participants at MSM sites

Does not report “always” using a condom during insertive or receptive anal sex with non-main (e.g., casual, one-time partner, sex worker) male partners in the prior 6 months

10

Number of non-main male sexual partners in prior 6 months [MSM]

Survey

Participants at MSM sites

Number of non-main male (e.g., casual, one-time partner, sex worker) male partners with whom the participant reports having insertive or receptive anal sex in the prior 6 months

11

Symptoms of sexually transmitted infection [MSM]

Survey

Participants at MSM sites

Reports genital/anal discharge, pain, or ulcer in prior 6 months

12

Syphilis infection

1. RPR test

2. TPHA test

Participants at MSM sites

Positive for syphilis infection by both RPR and TPHA tests

13

Shared injection equipment in prior 6 months [PWID]

Survey

Participants at PWID sites

Reports sharing (passing or receiving) a needle and/or syringe with another individual in the prior 6 months

14

Shared injection equipment at last use among active injectors [PWID]

Survey

Participants at PWID sites that report injection of one or more drugs in prior 6 months

Reports sharing (passing or receiving) a needle and/or syringe with another individual at last injection

15

Reported injection abstinence in prior 6 months [PWID]

Survey

Participants at PWID sites

Denies injecting any drug in prior 6 months

16

Hazardous alcohol use or dependence

Survey

All participants

Score ≥8 (hazardous) or ≥15 on Alcohol Use Disorder Identification Test (AUDIT) [61]

17

Depression

Survey

All participants

Score ≥ 10 on Patient Health Questionnaire (PHQ)-9 [62]

 Services and stigma

18

Spouse HIV testing among married participants

Survey

Participants who report being married

Reports spouse has ever been tested for HIV

19

Symptoms of sexually transmitted infection for which participant sought care in prior 6 months [MSM]

Survey

Participants at MSM sites

Reports genital/anal discharge, pain, or ulcer in prior 6 months AND reports seeking medical care for symptom(s)

20

Used needle/syringe exchange program (NSEP) in prior 6 months [PWID]

Survey

Participants at PWID sites

Reports NSEP use in prior 6 months

21

Used needle/syringe exchange program (NSEP) in prior 6 months among active injectors [PWID]

Survey

Participants at PWID sites that report injection of one or more drugs in prior 6 months

Reports NSEP use in prior 6 months

22

Used opioid agonist therapy (OAT) in prior 6 months [PWID]

Survey

Participants at PWID sites

Reports OAT in prior 6 months

23

Stigma subtypes

Survey

All participants

Summed score from each of four 6-item stigma scales (enacted, vicarious, felt normative, and internalized stigma) [63]

 Community viral load and HIV incidence

24

Prevalence of viremic individuals in population

1. Serologic HIV test

2. HIV RNA

All participants

Prevalence of HIV-positive subjects with HIV RNA >150c/mL [64]

25

Average viral load in HIV-positive participants

1. Serologic HIV test

2. HIV RNA

HIV seropositive participants

Average (log10) HIV RNA

26

HIV incidence

1. Serologic HIV test

2. HIV RNA

3. CD4 cell count

4. BED assay

5. Avidity index

Participants who meet criteria 1 or 2

1) HIV-seronegative

OR

2) HIV-seropositive participants who meet criteria for recent infection by HIV RNA, CD4, BED assay, and avidity assay

Cross-sectional HIV incidence estimated as described previously [6, 7, 64]