Table 1.
Characteristics of Studies Reviewed
| First author’s last name and year published |
Study participants | Place & length of study | HIV prevalence |
Counseling provided? |
Sensitivity
& specificity &/or concordance of test results |
How was test verified? |
Type of self- test used and specimen collected |
Supervised or unsupervised? |
Type of instruction? |
Quality
of included Studies (EPHPP & MMAT) |
|---|---|---|---|---|---|---|---|---|---|---|
| Asiimwe et al. 2014 | 246 adult fisherfolk in three communities at high risk for HIV infection | Lake Edward, Uganda. Research clinics for counseling and client’s homes or private location for unsupervised HST. Approx. 2 months. | 13.4% (33/246) | Pre-and post-test counseling | Unsupervised: Sensitivity:
90% Specificity: 95.26% Supervised: Sensitivity: 100% Specificity: 99.1% |
Determine, STAT-PAK, and Unigold. Subset of samples retested with Western Blot and ELISA | OraQuick lnHome Rapid HIV-1/2 Antibody Test. Oral. | Both supervised and unsupervised testing occurred. | Ten minute, in Person demonstration on test kit use. Written instructions included in HST. | EPHPP: Strong MMAT: 100% |
| Balan et al. 2014 | 27 HIV negative (HIV-) MSM at high risk of for HIV infection. | NYC, NY, USA. Kits given to participants to administer at home. Interviews administered at research offices. 3 months. | Participants: 0%
(0/27) Partners: 5.6% (7/124) |
NR | NR | Participants: Clearview Complete HIV-1/2 Partners: NR | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Participants: Supervised Partners: Could choose to be supervised or unsupervised. | Written instructions given to participants. Partners often tested with the participants and received demonstrations and coaching from them. | MMAT: 75% |
| Carballo-Dieguez et al. 2012 (J Sex Res) | 57 HIV negative (HIV-) MSM at high risk of for HIV infection. | NYC, NY, USA. Interviews & testing occurred at research offices. 3 months. | 0% (0/57) | NR | NR | Clearview Complete HIV-1/2 | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Supervised | Written instructions given to participants | MMAT: 75% |
| Carballo-Dieguez et al. 2012 (AIDS Behav) | Partners of 57 HIV negative (HIV-) MSM at high risk of for HIV infection. | NYC, NY, USA. Interviews & testing occurred at research offices. 3 months. | 5.6% (7/124) | No. | NR | NR | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Partners could choose to be supervised or unsupervised. | Partners often tested with the participants and received demonstrations and coaching from them | MMAT: 75% |
| Choko et al. 2011 | 283 adults | Urban Blantyre, Malawi. Community-health worker catchment areas. Testing done in homes. Approx. 5 months. | 18.5% (48/260) | Pre-and post-test counseling | Sensitivity 97.9% Specificity 100% Concordance: 99.2% |
Determine, Unigold, and SD Bioline HIV 1/2. | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Supervised. | In-person demonstration prior to test. | MMAT: 100% |
| Choko et al. 2015 | 16,660 adults (≥16 years old) | Blantyre, Malawi. 14 clusters of neighborhoods. Testing done in homes. 2 years. | Self-reported Year 1:
11.8% Year 2: 6.8% |
Pre-and post-test counseling | Sensitivity 93.6% Specificity 99.9% Concordance: 99.4% |
Determine, Alere, and Uni-Gold Recombigen. | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Unsupervised | In-person demonstration of test kit use | EPHPP: Strong MMAT: 100% |
| De La Fuente et al. 2012 | 313 participants of a street-based testing program | Madrid, Spain. Madrid Positivo, a mobile testing unit placed near areas with high-risk residents. Approx. 5 months. | 1.7% (9/519) | Pre- and post-test counseling. | Concordance: 92% | Determine HIV-1/2 Ag/Ab Combo performed by clinic staff. | Determine HIV-1/2 Ag/Ab Combo. Blood. | Supervised. | 207 participants received in-person demonstration 313 received written instructions. | EPHPP: Weak MMAT: 50% |
| Frasca et al. 2014 | 27 HIV negative (HIV-) MSM at high risk of for HIV infection. | New York City, NY, USA. Kits given to participants to administer at home. Interviews administered at research offices. 3 months. | NR | NR | NR | Participants: Clearview Complete HIV-1/2 Partners: NR | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Partners could choose to be supervised or unsupervised. | Partners often tested with the participants and received demonstrations and coaching from them. | MMAT: 75% |
| Gaydos et al. 2011 | 478 adult ED patients | Baltimore, MD, USA. 2 urban EDs. ~21 months. | 0.8% (4/478) | NR | 99.6% concordant | Standard oral fluid test. | OraQuick Advance Rapid HIV-1/2 Antibody test. Oral. Unigold test. Blood. | Supervised. | Written instructions. | EPHPP: Moderate MMAT: 75% |
| Gaydos et al. 2013 | 467 adult ED patients | Baltimore, MD, USA. John Hopkins ED. ~7 months. | 0.2% (1/467) | NR | 100% concordant. | Standard oral fluid test. Western Blot if necessary. | OraQuick Advance Rapid HIV-1/2 Antibody Test. Oral. | Supervised. | Tablet-based instructions. Written visual aid. | EPHPP: Weak MMAT: 50% |
| Kalibaba et al. 2014 | 765 health care workers (HCWs) from 7 different hospitals. | Kenya. Hospitals for demonstration and surveys, and clients homes for the self-testing. ~3 months. | NR | NR | NR | NR | CalypteR AwareTM. Oral. | Unsupervised. | Live demonstration and video on the use of the HST (optional). Written instructions. | EPHPP: Weak MMAT: 50% |
| Kumwenda et al 2014. | 34 participants (17 heterosexual couples) | Blantyre, Malawi. Clinic for interviews, client homes for self-testing. | NR | Pre- and post-test counseling. | NR | NR | OraQuick Advance Rapid HIV-1/2 Antibody Test. Oral. | Supervised &/or semi-supervised. | Written instructions. | MMAT: 100% |
| Kurth et al. 2015 | 240 adults (≥18 years) | Eldoret, Kenya. Recruitment from a health care facility and 2 community workplace settings. <1 month. | 15% (35/240) | Pre- and post-test counseling. | Sensitivity: 89.7%b Specificity: 98.0%b |
Determine HIV-1/2, Alere, & ELISA. | OraQuick Advance Rapid HIV-1/2 Antibody Test. Oral. | Participants were unsupervised, but a subset were videotaped performing the HST steps. | Pictorial instruction sheet in English and Kiswahili with text and icons. | MMAT: 75% |
| Lee et al. 2007 | 350 adults | Singapore. 2 testing centers. ~7 months. | NR | Pre- and post-test counseling. | Sensitivity:
98.9% Specificity: 99.6% Concordance: 43.4% |
HCW tested using Abbott Determine HIV 1/2 rapid test. Blood. | Abbott Determine HIV 1/2 rapid test. Blood. | Unsupervised. | Pictorial instructions | EPHPP: Weak MMAT: 50% |
| Lippman et al., 2015 | 50 HIV-transgender women | Center for AIDS prevention and home setting, San Francisco, CA, USA. 3 month study. | 0% (0/50) | Pre-and post-test counseling | NR. | HCW tested using Clearview HIV 1/2 STAT-PAK. Blood. | OraQuick InHome HIV tests. Oral. | Unsupervised. | Demonstration, and written instructions included in the HST. | MMAT: 75% |
| MacPherson et al., 2014 | 16,660 adults. | Home and facility-based groups, Blantyre, Malawi. 6 month period. | Home group: 6%
(490/8194) Facility group: 3.3% (278/8466) |
Pre- and posttest counseling | NR | Referred to study clinics for confirmatory testing. | OraQuick Advance Rapid HIV-1/2 antibody test. Oral. | Unsupervised | In-person demonstration of test kit use. | EPHPP: Strong MMAT: 100% |
| Marley et al., 2014 | 1,137 adults (MSM, FSW, and VCT clients). | Community locations in 4 cities in Shandong Province, China. Single visit. | 11.8% (40/340) | Pre-test counseling. | Sensitivity: 77.5%b Specificity: 99.76%b Concordance: Self-read vs. HCW 93.88%b Saliva vs. blood 97%b |
Consultant retested the participants with a blood test. | Not mentioned. | Supervised. | Written instructions included in the HST. | MMAT: 50% |
| Marlin et al., 2014 | 274 adults, primarily AA MSM. 50 were interviewed. | Community-based organization, LA, CA, USA. Single visit. | 6.1% (3/49) | NR | NR | NR | OraQuick InHome HIV test. Oral. | Unsupervised | Written instructions included in the HST. | EPHPP: Weak MMAT: 50% |
| Martinez et al., 2014 | 57 MSM at high risk for HIV | Clinic and home settings, NYC, NY, USA. 3 month study. | 0% (0/57) | NR | NR | NR | OraQuick Advance Rapid HIV-1/2 home test kit. Oral. | Supervised by the potential partner. | Written instructions on how to use the kit were provided. | MMAT: 75% |
| Ng et al., 2012 | 200 at-risk adults for HIV | 4 clinics that test for HIV, Singapore. Single visit. | 20.3% (202/994) | Pre- and post-test counseling | Sensitivity: 97.4%a Specificity: 99.9%a Concordance: 99.38% |
Repeated test by a trained healthcare worker. | OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. Oral. | Unsupervised. | Pictoral instruction sheet designed by the study team. | EPHPP: Weak MMAT: 75% |
| Nour et al., 2012 | 249 adult ED patients | Johns Hopkins ED, Baltimore, MD, USA. Single visit. | 1.6% (4/249) | NR | 100% concordance | Repeated oral-based test from a HCW. | OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. Oral. | Unsupervised. | Given large instruction templates as a visual aid. | EPHPP: Moderate MMAT: 75% |
| Pant Pai et al., 2013 | 251 HCW | Groote Schurr Hospital, Cape Town, South Africa. Single visit. | 3.6% (9/251) | Pre- and post-test counseling | 98.7% concordant Sensitivity: 66.7% Specificity: 100% |
Confirmatory rapid and lab tests | OraQuick Rapid HIV-1/2 Antibody Test. Oral. | Unsupervised. | Video and picture instructions for self-testing. | MMAT: 50% |
| Pant Pai et al., 2014 | 145 university students | Student health clinic in a Canadian University, Montreal, Canada. Single visit. | 0% (0/145) | Pre- and post-test counseling | 100% concordance with HCW test. | ELISA blood test (done before selftesting) | OraQuick Rapid HIV-1/2 Antibody Test. Oral. | Unsupervised. | Video instructions or a pamphlet and pictoral reference guide. | MMAT: 50% |
| Peck et al., 2014 | Kenya: 150 Malawi: 47 South Africa: 54 Total: 251 adults | VCTs in Kenya, district HIV clinics in Malawi, office in community setting in South Africa. Single visit. | NR | NR | NR | NR | 5 prototype tests used. One was an oral test and 4 were fingerstick blood tests. | Supervised via a video monitor. | Pictorial and written instructions were provided with the testing kits. | MMAT: 75% |
| Schnall et al., 2015 | 21 adults aged 18-24 years old at high risk for HIV | Columbia Community Partnership for Health, USA. Single visit. | 0% (0/21) | NR | NR | NR. | Test brand not mentioned. Oral. | Supervised through a oneway mirror, but participants were aware of the supervision. | Written instructions included in the HST. | MMAT: 75% |
| Tao et al., 2014 | 220 MSM | Homes of study participants, China. | 15% (33/220) | Pre- and post-test counseling | 100% concordanceb | Western Blot used to confirm self-test positive results. | Human Immuno-deficiency Virus HIV K Antibody Rapid Test. Blood. | Unsupervised. | Online video instruction. | EPHPP: Weak MMAT: 50% |
| Volk et al., 2015 | 103 HIV- adult MSM at high risk for HIV infection. | 1 clinic in Rio de Janeiro, Brazil, and 2 clinics in Lima, Peru. 3 monthly visits. | 1.94% (2/103) | Pre- and post-test counseling | 100% concordance | Confirmed status prior to enrollment in the study. | Clearview COMPLETE HIV 1/2 Assay. Blood. | Unsupervised for the first two tests, supervised during the last follow-up visit. | Demonstration, as well as pictoral and written instructions. | EPHPP: Weak MMAT: 75% |
| Young et al., 2014 | 8 African-American and Latino MSM. | Gay and Lesbian Center, Hollywood, CA, USA. One time interview. | NR | NR | NR | NR | OraQuick ADVANCE Rapid HIV-1/2 Antibody test. Oral. | Unsupervised. | Written instructions included in the HST. | MMAT: 50% |
Not reported = NR
a
Analysis excludes invalid results
b
Analysis done on a subset of study participants