| Literature DB >> 32991337 |
Matthew D Hickey1, James Ayieko2, Dalsone Kwarisiima3, Fredrick J Opel2, Asiphas Owaraganise3, Laura B Balzer4, Gabriel Chamie1, Vivek Jain1, James Peng1, Carol Camlin5, Edwin D Charlebois5, Craig R Cohen6, Elizabeth A Bukusi2, Moses R Kamya3,7, Maya L Petersen8, Diane V Havlir1.
Abstract
BACKGROUND: HIV differentiated service delivery (DSD) models are scaling up in resource-limited settings for stable patients; less is known about DSD outcomes for patients with viremia. We evaluated the effect on viral suppression (VS) of a streamlined care DSD model implemented in the SEARCH randomized universal test and treat trial in rural Uganda and Kenya (NCT:01864603).Entities:
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Year: 2020 PMID: 32991337 PMCID: PMC7654939 DOI: 10.1097/QAI.0000000000002508
Source DB: PubMed Journal: J Acquir Immune Defic Syndr ISSN: 1525-4135 Impact factor: 3.771
FIGURE 1.Study flow diagram.
Baseline Characteristics by the Study Arm
| Intervention (n = 3394) | Control (n = 2796) | |||
| n or Median | % or IQR | n or Median | % or IQR | |
| Region, n (%) | ||||
| Eastern Uganda | 422 | 12% | 302 | 11% |
| Kenya | 2308 | 68% | 1938 | 69% |
| Western Uganda | 664 | 20% | 556 | 20% |
| Male sex, n (%) | 1130 | 33% | 948 | 34% |
| Age category, n (%) | ||||
| 15–24 yrs | 327 | 10% | 211 | 8% |
| 25–49 yrs | 2411 | 71% | 2067 | 74% |
| ≥50 yrs | 656 | 19% | 518 | 19% |
| Marital status, n (%) | ||||
| Single | 198 | 6% | 134 | 5% |
| Married | 2267 | 68% | 1875 | 67% |
| Widowed/Divorced/Separated | 879 | 26% | 773 | 28% |
| Occupation | ||||
| Formal sector | 165 | 5% | 113 | 4% |
| High-risk informal | 327 | 10% | 523 | 19% |
| Low-risk informal | 2505 | 74% | 1801 | 64% |
| No job or disabled | 173 | 5% | 193 | 7% |
| Others or missing | 224 | 7% | 166 | 6% |
| Baseline pregnancy, n (%, of women) | 114 | 5% | 99 | 5% |
| Time since ART initiation (yr), median (IQR) | 3.2 | 2.6–3.7 | 3.5 | 3.1–3.8 |
| Time from baseline community health fair to next clinic visit (d), median (IQR) | 51 | 24–93 | 42 | 20–103 |
| Baseline CD4, n (%) | ||||
| <200 | 372 | 11% | 304 | 11% |
| 200–350 | 828 | 24% | 606 | 22% |
| 351–500 | 586 | 17% | 499 | 18% |
| >500 | 1262 | 37% | 1120 | 40% |
| Missing | 346 | 10% | 267 | 10% |
| Comorbid conditions, n (%) | ||||
| Hypertension | 278 | 9% | 222 | 9% |
| Diabetes | 40 | 1% | 39 | 2% |
| Baseline care status, n (%) | ||||
| ART-experienced, baseline viremia | 330 | 10% | 238 | 9% |
| ART-experienced, baseline suppression | 1646 | 48% | 1311 | 47% |
| ART-experienced, baseline VL missing | 904 | 27% | 896 | 32% |
| ART-naïve, CD4 ≤ 350 | 514 | 15% | 351 | 13% |
A formal sector occupation was defined as a teacher, student, government worker, military worker, health worker, or factory worker. A high-risk informal sector occupation was defined as a fishmonger, fisher, bar owner, bar worker, transportation worker, or tourism worker. A low-risk informal sector occupation was defined as a farmer, shopkeeper, market vendor, hotel worker, homemaker, household worker, construction worker, or miner.
A community health fair was conducted at baseline in all communities with nonattendees tracked in the community for baseline HIV testing. The time calculated from date of community health fair to the first/next clinic visit.
Viral load ≥ 500 copies/mL.
Viral load < 500 copies/mL.
Streamlined Care Visit Interval
| ART-Experienced With Baseline Viremia | ART-Naive With Baseline CD4 ≤350 | ART-Experienced With Baseline VS | ||||
| Intervention (N = 330) | Control (N = 238) | Intervention (N = 514) | Control (N = 351) | Intervention (N = 1646) | Control (N = 1312) | |
| Visit interval, median d (IQR) | ||||||
| Year 1 | 50 (37–62) | 39 (32–50) | 42 (31–50) | 36 (28–46) | 58 (47–70) | 47 (36–56) |
| Year 2 | 63 (43–79) | 43 (31–54) | 70 (51–84) | 50 (36–58) | 75 (63–84) | 51 (40–58) |
| Year 3 | 65 (42–83) | 46 (33–57) | 70 (55–84) | 51 (38–58) | 78 (64–84) | 56 (43–62) |
Viral load ≥ 500 copies/mL.
Viral load < 500 copies/mL.
Effect of Streamlined Care on Engagement and Retention in Care
| ART Experienced with Baseline Viremia | ART Naive With Baseline CD4 ≤350 | ART Experienced With Baseline VS | |||||||
| Intervention (N = 330) | Control (N = 238) | RR (95% CI) | Intervention (N = 514) | Control (N = 351) | RR (95% CI) | Intervention (N = 1646) | Control (N = 1312) | RR (95% CI) | |
| VS at year 3 | 67% | 47% | 1.41 (1.05 to 1.91) | 83% | 79% | 1.05 (0.95 to 1.16) | 97% | 95% | 1.01 (1.00 to 1.03) |
| Men | 66% | 55% | 1.21 (0.89 to 1.65) | 78% | 72% | 1.09 (0.91 to 1.30) | 96% | 95% | 1.01 (0.98 to 1.03) |
| Women | 66% | 44% | 1.52 (1.01 to 2.28) | 88% | 86% | 1.03 (0.93 to 1.14) | 97% | 96% | 1.01 (1.00 to 1.03) |
| Time in care (TIC) | 81% | 73% | 1.11 (1.02 to 1.19) | 74% | 67% | 1.10 (1.03 to 1.17) | 86% | 81% | 1.07 (1.01 to 1.13) |
| Men | 81% | 71% | 1.15 (1.01 to 1.30) | 72% | 66% | 1.10 (0.98 to 1.22) | 86% | 83% | 1.04 (1.00 to 1.09) |
| Women | 81% | 75% | 1.08 (0.98 to 1.20) | 75% | 68% | 1.10 (1.01 to 1.19) | 86% | 80% | 1.08 (1.01 to 1.15) |
| Proportion with missed visit by ≥90 d at 30 mo | 30% | 40% | 0.75 (0.58 to 0.98) | 36% | 46% | 0.79 (0.65 to 0.96) | 21% | 29% | 0.75 (0.46 to 1.20) |
| Men | 34% | 39% | 0.87 (0.57 to 1.33) | 37% | 49% | 0.75 (0.55 to 1.03) | 23% | 24% | 0.96 (0.66 to 1.38) |
| Women | 28% | 40% | 0.69 (0.47 to 1.03) | 35% | 43% | 0.81 (0.62 to 1.07) | 21% | 30% | 0.68 (0.40 to 1.16) |
Viral load ≥500 copies/mL.
Viral load <500 copies/mL.
Switch to Second-Line ART Among ART-Experienced Patients With Baseline Viremia
| ART Experienced With Baseline viremia | |||
| Intervention (N = 330) | Control (N = 238) | RR (95% CI) | |
| ART regimen at study baseline | |||
| First line (NNRTI-based) | 310 (94%) | 219 (92%) | |
| Second line (PI-based) | 18 (5%) | 12 (5%) | |
| Unknown | 2 (1%) | 7 (3%) | |
| Switch to second-line ART | 53 (17%) | 23 (10%) | 1.61 (0.81 to 3.32) |
| Year 3 viral suppression by the switch status | |||
| Remain on first-line ART | 65% | 45% | 1.43 (1.09 to 1.87) |
| Switch to second-line ART | 78% | 58% | 1.35 (0.83 to 2.21) |
Viral load ≥500 copies/mL.
Switch to second-line PI-based ART among those on first-line NNRTI-based ART at baseline.