Study, yr; type of couple | Study design and period | Study location | No. (%) of HIV-positive partners, by sex | Adherence to ART | Timeline for viral load testing | Limit of detection for VL assay, copies/mL | Condom use reported by HIV-positive partners on ART, No. (%)* | No. (%) of partners with ST Is | Frequency of testing for HIV | Primary outcome(s) of interest |
---|---|---|---|---|---|---|---|---|---|---|
Randomized controlled trial | ||||||||||
Cohen et al., 201650 (HIV Prevention Trial Network [HPTN] 052); Het (97%) | RCT: 2005–2015† | Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, US, Zimbabwe | At baseline: F: 873 (49.5) M: 890 (50.5) | At interim analysis (2011), 79% and 74% of early and delayed arms, respectively, reported 95% adherence as measured by pill counts.‡ | Baseline; every mo for the first 3 mo; every 3 mo after; at seroconversion | 400 | 100% condom use reported at interim analysis: early ART arm, 96%; delayed ART arm, 95% | Cumulative incidence for syphilis: HIV+: 144 (8.2), HIV−: 103 (5.7); for gonorrhea: HIV+: 102 (5.8) HIV−: 74 (4.1) | Every 3 mo | HIV incidence on ART |
Observational study | ||||||||||
Grulich et al., 201551 (Opposites Attract Study); MSM | Prospective cohort: 2012–ongoing | Australia, Thailand, Brazil | Total enrolled: M: 234 (100.0) | NR | Baseline; follow-up (≥ 2 per yr); at seroconversion | 20–150 based on the study site | NR; reports on condomless acts | Baseline STI prevalence: HIV+: 17§ (11.2) HIV−: 10§ (6.6) | Baseline; follow-up (≥ 2 per yr) | HIV incidence on ART by VL and type of sex act |
Rodger et al., 201655 (Partners of People on ART — A New Evaluation of Risks [PARTNER] Study); Het/MSM | Prospective cohort: Het: 2010–2014 MSM: 2010–ongoing | Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, Spain, Sweden, Switzerland, Netherlands, UK | Het: F: 279 (31.4§) M: 269 (30.3§) MSM: 340 (38.3§) | 93% of Het men, 94% of Het women and 97% of MSM self-reported > 90% adherence | Every 4–6 mo | 50 | NR; reports on condomless acts | Any STI at follow-up: Het: HIV+: 32 (5.8) HIV−: 33 (6.0) MSM: HIV+: 59 (17.4) HIV−: 56 (16.5) | Every 4–6 mo | HIV incidence on ART and virally suppressed by type of sex act |
Mujugira et al., 201654 (Partners Pre-Exposure Prophylaxis [PrEP] Study); Het | Prospective cohort: 2008–2012 | Kenya, Uganda | Among those who started ART (83%): F: 1062 (58.4) M: 755 (41.6) | NR | Baseline; every 6 mo; final visit | 40 | HIV− partner reported condomless sex: at 10.5% of visits during < 6 mo on ART; at 9.1% of visits during > 6 mo on ART | NR | Every mo | HIV incidence on ART by ART duration (≤ 6 mo, > 6 mo) |
Birungi et al., 201552 (Highly Active Antiretroviral therapy as Prevention [HAARP] Study); Het | Prospective cohort: 2009–2011 | Uganda | F: 255 (43.5) M: 331 (56.5) | All 5 linked transmissions reported “never” missing ART, and 0 pills missed in last week | Every 6 mo | 20 | Condom use at last sex reported at baseline: 256§ (73.6)§ | HSV-2 at enrolment: HIV+: 510§ (87.0)§ HIV−: 470§ (80.2)§ | Baseline; every 3 mo | HIV incidence on ART by ART duration: (≤ 3 mo, > 3 mo) |
He et al., 2013;53 Het | Prospective cohort: 2009–2011 | China | Retained in cohort: F: 167§ (20.5) M: 646§ (79.5) | NR | Baseline; ≥ 12 mo | 50 | Condom use over past 12 mo reported at baseline: Consistent: 295 (76.4) Inconsistent: 52 (13.5) No sex: 39 (10.1) | At baseline: Syphilis: HIV+: 23 (3.2) HIV−: 9 (1.2) HSV-2: HIV+: 262 (36.4) HIV−: 226 (30.0) | Baseline; ≥ 12 mo | HIV incidence on ART |
Del Romero et al., 2015;49 Het | Prospective cohort: 1989–2010 | Spain | Participants with follow-up: F: 84§ (17.9) M: 385 (82.1) | NR | Baseline; every 6 mo | 500 before 1999; 50 thereafter | Couples with condomless acts at follow-up: 115 (58.0) | Any STI at follow-up in either partner: Total: 9 (1.9)§ On ART: 2 (1.0)§ | Baseline; every 6 mo | HIV incidence on ART by condom use |
Reynolds et al., 201147 (Rakai Community Cohort Study [RCCS]); Het | Retrospective cohort: 2004–2009 | Uganda | F: 105 (42.0)§ M: 145 (58.0) | NR | Every 6 mo | 400 | Condom use reported by HIV− partner at follow-up: Consistent: 22 (53.7) Inconsistent: 14 (34.2) Never/not in 12 mo: 5 (12.2) | Cumulative incidence of self-reported genital ulcer disease: HIV+ on ART: 1 (2.4) | Every 12 mo | HIV incidence on ART |
Donnell et al., 201045 (Partners in Prevention HSV/HIV Transmission Study); Het | Prospective cohort: 2004–2008 | Botswana, Kenya, Rwanda, South Africa, Tanzania | F: 2284 (67.5) M: 1097 (32.4) | NR | Baseline; at 3 mo; at 6 mo; at 12 mo; at final visit | 240 | Reported during study: some condom use (96.3% of visits)§ | HSV-2 at enrolment: HIV+: 3381 (100.0) HIV−: 2294 (67.9) | Every 3 mo | HIV incidence on ART |
Apondi et al., 2011;44 Het | Prospective cohort: 2003–2007 | Uganda | NR | Self-reported “excellent” adherence was 74%–81% at quarterly interviews. | Every 3 mo | 50 | Always used a condom over the past 3 mo: Baseline: 18§ (58.6%) At 6-mo follow-up: 37§ (78.7%) At 36-mo follow-up: 42§ (73.7%) | NR | At 12 mo; at 24 mo; at 36 mo | HIV incidence on ART |
Melo et al., 2008;46 Het | Retrospective and prospective cohorts: 2000–2006 | Brazil | F: 67 (72.0) M: 26 (28.0) | NR | Every 6 mo | 50 | Baseline assessment of 37 couples: Some condom use: F: 16 (66.7)§ Regular condom use: M: 13 (100.0) | Total STI: 22 (23.6) Genital herpes: 8 (36.4) Syphilis: 4 (18.2) | Every 6 mo | HIV incidence on ART |
Note: ART = antiretroviral therapy, F = female, Het = heterosexual, HIV+ = HIV-positive, HIV− = HIV-negative, HSV-2 = herpes simplex virus type 2, IQR = interquartile range, M = male, MSM = men who have sex with men, NR = not reported, PrEP = pre-exposure prophylaxis, RCT = randomized controlled trial, SD = standard deviation, STI = sexually transmitted infection, VL = viral load.
↵* Unless stated otherwise.
↵† HPTN 052 began pilot testing in 2005. Enrolment commenced in 2007.
↵‡ In this study, the percentage adherence by pill count was determined by comparing the number of pills taken versus the number that should have been taken since ART initiation.40,64
↵§ Value calculated by the research team.