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01.12.2018 | Research article | Ausgabe 1/2018 Open Access

BMC Public Health 1/2018

Which user errors matter during HIV self-testing? A qualitative participant observation study of men who have sex with men (MSM) in China

Zeitschrift:
BMC Public Health > Ausgabe 1/2018
Autoren:
Chongyi Wei, Li Yan, Jianjun Li, Xiaoyou Su, Sheri Lippman, Hongjing Yan
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12889-018-6007-3) contains supplementary material, which is available to authorized users.
Abbreviations
CBOs
Community-based organizations
CDC
Center for Disease Control and Prevention
HIVST
HIV self-testing
MSM
men who have sex with men

Background

HIV self-testing (HIVST), the process in which a person collects his/her own specimen (oral fluid or blood) and then performs an HIV test and interprets the results in private, is recommended by the World Health Organization as an additional approach to HIV testing services [1]. Review of evidence demonstrated that HIVST was highly acceptable to many users including key populations, more than doubled uptake of HIV testing among men who have sex with men (MSM), could result in identifying an equivalent or greater proportion of HIV-positive individuals, and could achieve acceptable sensitivity (80–100%) and specificity (95–100%) [25]. This timely recommendation can help attain the first of the United Nation’s 90–90-90 targets, as many individuals remain unaware of their HIV serostatus [6].
HIVST is particularly suitable for expanding HIV testing services among MSM, who are disproportionally affected by HIV, and do not always access facility-based testing in contexts where MSM-related stigma and discrimination are prevalent [2, 79]. MSM account for a third and rising proportion of new HIV infections in China, which is in part due to lack of regular testing [10, 11]. Although not officially endorsed by the Chinese health authorities, HIVST kits are readily accessible through some community-based organizations and can be easily purchased on the Internet. Several recent cross-sectional surveys of Chinese MSM reported that between 20 and 29% of participants had ever self-tested for HIV [1214]. Furthermore, one study found that 59% of men who self-tested reported HIVST as their first HIV testing experience [12].
As substantial numbers of Chinese MSM are already using HIVST, it is important to ensure that the tests are used correctly to improve diagnostic accuracy, especially in an unregulated market where quality of HIVST kits can vary. In fact, a study reported that just 24% of Chinese MSM who ever self-tested said they were “very confident” in the accuracy of their test results and 73% perceived self-testing to be less accurate compared to facility-based testing [13]. Therefore, this participant observation study aimed to assess to what extent HIVST was conducted correctly by Chinese MSM and to identify common user errors during the HIVST process. Such findings can inform strategies to optimize HIVST use and thus reduce the number of undiagnosed HIV infections.

Methods

Between February 25th and March 5th, 2017, participant observations were conducted with 27 MSM in an east coastal city in China. Purposive sampling was used to recruit a diverse group of participants in terms of age, education and history of HIV testing. Participants were recruited through referrals from two local community-based organizations (CBOs) which offer HIV prevention services to MSM. To be eligible, participants had to be born male, 18 years old or older, a local resident, speak either Mandarin or the local dialect, have had sex with another male in the past 12 months, and self-report being HIV-negative or unknown status.
Participant observations were conducted in a private room at the Provincial Center for Disease Control and Prevention (CDC). Two types of HIV self-testing kits, finger prick (AIJI Colloidal Cold, HIV-1/2, NewScen Coast Bio-Pharmaceutical Co., Ltd., Tianjin, China) and oral fluid (Aware HIV-1/2 OMT, Beijing Marr Bio-Pharmaceutical Co., Ltd., Beijing, China), were offered to participants where they could choose to use either one based on preference. In the presence, but without the assistance or orientation, of a trained HIV testing counselor, participants conducted self-testing procedures according to the manufacturers’ text- and pictorial-based instructions. During the direct observations, the counselor recorded errors made by the participants using two checklists (one for each type of HIVST. Please see Additional files 1 and 2 for the checklists). Each participant observation was also video recorded. A research assistant reviewed the videos afterwards and double checked to ensure that the user errors were correctly marked on the checklists. All participants conducted a second HIVST with the assistance of the counselor after completing the self-testing procedures on their own. Participants who tested preliminary positive were offered confirmatory testing on site. The provincial CDC followed up with diagnosed HIV-positive individuals for CD4 and viral load testing and referred them to the local designated hospital for treatment.
Participation in the study was anonymous and voluntary. An incentive of 100 RMB (~ 15 USD) was offered to compensate for participants’ time and effort. The study was approved by the University of California San Francisco, Rutgers University and Jiangsu Provincial CDC’s Institutional Review Boards.

Results

A total of 27 eligible men participated in the study. A majority (63.0%) of participants were between the ages of 20 and 29. About three quarters either completed some college (33.3%) or had an educational level of college or above (40.7%). Most (88.9%) were single/never married. Over half (59.3%) self-identified as gay while a third (33.3%) self-identified as bisexual. About half (44.4%) reported that they had a main male sex partner at the time of this study. Just under a third (29.6%) reported condomless anal sex in the past 6 months. In terms of history of HIV testing, 48.1% had never been tested for HIV while 33.3% said they had conducted HIV self-testing before (Table 1).
Table 1
Socio-demographic and behavioral characteristics of MSM participants (N = 27)
 
n (%)
Age
 18–19
1 (3.7%)
 20–29
17 (63.0%)
 30–40
9 (33.3%)
Educational level
 High school or below
7 (25.9%)
 Some college
9 (33.3%)
 College or above
11 (40.7%)
Marital status
 Single
24 (88.9%)
 Married
1 (3.7%)
 Divorced/separated
2 (7.4%)
Employment status
 Full-time
18 (66.7%)
 Part-time
1 (3.7%)
 Student
7 (25.9%)
 Unemployed
1 (3.7%)
Sexual orientation
 Gay
16 (59.3%)
 Bisexual
9 (33.3%)
 Heterosexual
0 (0%)
 Unsure
2 (7.4%)
Have a main male sex partner
 Yes
12 (44.4%)
 No
15 (55.6%)
Condomless anal sex in the past 6 months
 Yes
8 (29.6%)
 No
19 (70.4%)
Ever tested for HIV
 Yes
14 (51.9%)
 No
13 (48.1%)
Ever self-tested for HIV
 Yes
9 (33.3%)
 No
18 (66.7%)
Of the 27 participants, 15 (55.6%) chose to use finger prick self-testing while the rest (44.4%) preferred oral fluid (Table 2). Overall, 12 (44.4%) had invalid test results due to user errors but were all re-tested as HIV-negative. Just five (18.5%) did not make any errors during the entire HIV self-testing process. Two (7.4%) self-tested positive and were re-tested HIV-positive.
Table 2
Numbers of errors made by MSM participants during HIV self-testing process and results of self-testing and retest (N = 27)
HIV self-testing modality: Finger prick (N = 15)
Participant #
Age
Education
HIV testing history
Numbers of errors made
Test result
Retest
Preparing the test (n = 0–2)
Administering the test (n = 0–4)
Interpreting the result (n = 0–1)
Total (n = 0–7)
1
18–29
Some college
Ever self-tested
2
2
0
4
Negative
Negative
2
18–29
≥ College
Ever self-tested
1
2
0
3
Negative
Negative
3
18–29
Some college
Ever self-tested
0
3
1
4
Invalid
Negative
4
30–40
Some college
Ever self-tested
1
1
0
2
Negative
Negative
5
18–29
≥ College
Ever self-tested
0
1
1
2
Invalid
Negative
6
30–40
Some college
Ever self-tested
1
2
1
4
Invalid
Negative
7
18–29
Some college
Ever self-tested
1
2
0
3
Negative
Negative
8
30–40
≥ College
Ever self-tested
1
1
0
2
Negative
Negative
9
18–29
≥ College
Ever testeda
0
0
0
0
Negative
Negative
10
18–29
≤ High school
Never tested
1
4
1
6
Invalid
Negative
11
18–29
≥ College
Never tested
1
2
0
3
Positive
Positive
12
30–40
≤ High school
Never tested
0
3
1
4
Invalid
Negative
13
18–29
≥ College
Never tested
0
3
0
3
Negative
Negative
14
18–29
≥ College
Never tested
0
3
0
3
Negative
Negative
15
18–29
≥ College
Never tested
0
2
1
3
Invalid
Negative
HIV self-testing modality: Oral fluid (N = 12)
    
Numbers of errors made
  
Preparing the test (n = 0–3)
Conducting the test (n = 0–7)
Interpreting the result (n = 0–2)
Total (n = 0–12)
16
18–29
≤ High school
Ever self-tested
3
6
2
11
Invalid
Negative
17
30–40
≤ High school
Ever testeda
1
4
0
5
Negative
Negative
18
18–29
Some college
Ever testeda
1
7
2
10
Invalid
Negative
19
18–29
≥ College
Ever testeda
0
2
2
4
Invalid
Negative
20
30–40
≥ College
Ever testeda
0
0
0
0
Negative
Negative
21
30–40
≤ High school
Never tested
1
6
2
9
Invalid
Negative
22
18–29
Some college
Never tested
0
0
0
0
Negative
Negative
23
18–29
≤ High school
Never tested
1
6
2
9
Invalid
Negative
34
18–29
≥ College
Never tested
0
0
0
0
Negative
Negative
25
30–40
Some college
Never tested
0
0
0
0
Negative
Negative
26
30–40
≤ High school
Never tested
0
4
2
6
Positive
Positive
27
18–29
Some college
Never tested
0
3
1
4
Invalid
Negative
aAt a facility (e.g., CDC, CBO, hospital), excluding self-testing
Among finger prick self-testers, 6 (40.0%) had invalid test results (Table 2). Only one participant (6.7%) did not make any error, who was a frequent HIV tester although never self-tested before. Among those who made errors, total numbers of errors ranged from two to six (maximum = 7). During the stage of administering the test, a majority (10/14, 71.4%) made two or three errors (maximum = 4). The most common errors included: difficulties in using the lancet and the micro pipette to draw blood; insufficient amount of blood drawn from finger; and failure to follow all the steps. Notably, of the 8 participants who self-tested before, three (37.5%) had invalid test results and all made some errors during the process.
Among oral fluid self-testers, 6 (50.0%) had invalid test results (Table 2). Four participants (33.3%) did not make any error. Among those who made errors, total numbers of errors ranged from four to 11 (maximum = 12). During the stage of administering the test, a majority (6/8, 75.0%) made four or more errors (maximum = 7). The most common errors included: failure to follow all the steps; removing the membrane surface from the assay test strip; and placing the test strip upside down in the tube containing the diluted specimen.

Discussion

This participant observation study found that when unassisted, a majority of Chinese MSM participants made some user errors during the process of conducting HIVST. Some of the errors were significant enough that almost half of the test results were rendered invalid. Our finding is consistent with prior research that sensitivity of HIVST was reduced among individuals in unsupervised or unassisted settings [5, 15]. Failure to follow all the steps according to manufactures’ instructions was a common problem for both finger prick and oral fluid self-testers. For finger prick users, most errors occurred during the stage of collecting the specimen. In contrast, oral fluid users made most errors during the stage of testing the collected specimen.
There were no clearly discernible patterns between participants’ histories of HIV testing and numbers of user errors or self-testing results; having previously tested for HIV did not facilitate the conduct of HIVST. In fact, a third of the invalid test results were observed among participants who self-tested before. It did appear, however, that participants with lower educational level were more prone to making errors. Of the 7 men who completed high school or below, almost three quarters 9 (5/7, 71.4%) had invalid test results. This may not be surprising given that the manufactures’ instructions were mainly text-based.
Several limitations of this study should be noted. First, our sample of participants were referred by CBOs that provided HIV testing services to MSM. However, we purposefully recruited men who were diverse in terms of age, education, and history of HIV testing. Second, we only provided HIVST kits from two manufacturers. Kits from other manufacturers might have included improved instructions. However, these two manufactures are currently the main vendors of HIVST kits in China. Third, due to the presence of an HIV testing counselor and video recording, some participants might have felt uneasy or nervous leading them to make unnecessary user errors. However, our finding is consistent with those from previous studies [5, 15]. Finally, this was a relatively small sample of MSM participants, but the qualitative methodology (i.e., participant observation) provides contextual information of the HIVST process and is not intended to generalize. The findings could inform future surveys that quantify the error types and their magnitude.

Conclusions

Although we found that user errors were common among MSM administering HIVST, this should not deter or discourage routine implementation and scale-up of HIVST as strong evidence shows that the benefits of reaching untested MSM and increasing frequency of testing among this population outweigh the disadvantages (e.g., reduced but acceptable sensitivity). A few strategies could be implemented to facilitate the correct conduct of HIVST. First, in addition to text- and pictorial-based instructions, manufacturers should provide video instructions that use simple but clear language (e.g., OraSure Technologies provides video instructions in multiple languages). This would especially benefit men with low or limited health literacy. Second, for those who wish to access free kits through CBOs, HIV testing counselors could offer orientation or instruction before men take the kits home. Finally, health authorities should continuously and comprehensively monitor the quality of HIVST kits sold on the market so that individuals can make informed choices.

Acknowledgments

We thank the collaborations from the community-based organizations and participants, and we would also thank the people in Jiangsu provincial CDC of China who contributed to study design and data collection for this study.

Funding

This study was supported from a grant from the National Institute of Mental Health (grant number: 1R34MH109359). The funding bodies had no role in the design of the study and collection, analysis, and interpretation of data and writing the manuscript.

Availability of data and materials

The dataset generated during and/or analyzed during the current study is not publicly available due to potential breach of confidentiality for the participants: small sample size, sensitive information (i.e., HIV-infected status), and video-recording of the procedures.

Ethics approval and consent to participate

Participation in this study was voluntary and written informed consent was obtained from all participants. The study was approved by the ethics committees of UCSF, Rutgers University and Jiangsu CDC of China.

Consent for publication

Not applicable

Competing interests

CW is a member of the Editorial Board of BMC Public Health. The authors declare that they have no other competing interests.

Publisher’s Note

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Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://​creativecommons.​org/​licenses/​by/​4.​0/​), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://​creativecommons.​org/​publicdomain/​zero/​1.​0/​) applies to the data made available in this article, unless otherwise stated.
Zusatzmaterial
Additional file 1: Participant observation checklist: checklist for finger prick HIV self-test. (DOC 16 kb)
12889_2018_6007_MOESM1_ESM.doc
Additional file 2: Participant observation checklist: checklist for oral swap HIV self-test. (DOC 28 kb)
12889_2018_6007_MOESM2_ESM.doc
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