|Year : 2020 | Volume
| Issue : 5 | Page : 22-25
Is Inclusion of informed consent associated with HIV seropositivity rate? findings from 2017 HIV sentinel surveillance among men having sex with men in select states of India
Partha Haldar1, Shreya Jha2, Ramashankar Rath3, Kiran Goswami4, Nishakar Thakur5, Pradeep Kumar6
1 Associate Professor, Centre for Community Medicine, AIIMS, New Delhi, India
2 Consultant, Centre for Community Medicine, AIIMS, New Delhi, India
3 Assistant Professor, Department of Community Medicine and Family Medicine, AIIMS, Gorakhpur, Uttar Pradesh, India
4 Professor, Centre for Community Medicine, AIIMS, New Delhi, India
5 Statistician, Centre for Community Medicine, AIIMS, New Delhi, India
6 Program Officer - Surveillance, National AIDS Control Organization, MoHFW, GOI, New Delhi, India
|Date of Submission||30-Oct-2019|
|Date of Decision||24-Jan-2020|
|Date of Acceptance||06-Feb-2020|
|Date of Web Publication||14-Apr-2020|
Dr. Shreya Jha
Centre for Community Medicine, Old OT Block, AIIMS, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: During round 2017 of HIV Sentinel Surveillance (HSS) for men who have sex with men (MSM) in India, sampling strategy was changed from consecutive sampling to random sampling, and recruitment was conditioned on informed written consent. Objective: The study aimed to explore whether inclusion of informed consent is associated with HIV seropositivity rates among MSM population in select four states of Central India. Methods: The cross-sectional study was conducted in four states of Delhi, Jharkhand, Uttar Pradesh, and Uttarakhand that were supervised by All India Institute of Medical Sciences, New Delhi. We did analysis of data collected during 2017 HSS, supplemented with additional program data from targeted intervention (TI) sites. All nine MSM sites in four states were included. Participants were defined as all those MSM who participated in HSS 2017 irrespective of whether they were mentioned in the random list or were selected by the TI partner. The MSM in the random list who either refused to participate or could not be contacted even after three attempts were classified as “nonparticipants.” Seropositivity of both groups was compared. Descriptive statistics were derived. Results: Overall nonparticipation rate was 14.7%, the highest being in Jharkhand (26%) and lowest in Uttarakhand (6.8%). Overall HIV positivity rate was significantly higher (P < 0.001) in nonparticipants (4.2%) when compared to participants (1.42%). Conclusion: The change in sampling strategy and introduction of written informed consent for recruitment of high-risk groups in HSS 2017 round could have led to an underestimation of HIV seropositivity rate among MSM in the states in Central Zone.
Keywords: Female sex workers, HIV prevalence, HIV Sentinel Surveillance, men who have sex with men
|How to cite this article:|
Haldar P, Jha S, Rath R, Goswami K, Thakur N, Kumar P. Is Inclusion of informed consent associated with HIV seropositivity rate? findings from 2017 HIV sentinel surveillance among men having sex with men in select states of India. Indian J Public Health 2020;64, Suppl S1:22-5
|How to cite this URL:|
Haldar P, Jha S, Rath R, Goswami K, Thakur N, Kumar P. Is Inclusion of informed consent associated with HIV seropositivity rate? findings from 2017 HIV sentinel surveillance among men having sex with men in select states of India. Indian J Public Health [serial online] 2020 [cited 2020 May 29];64, Suppl S1:22-5. Available from: http://www.ijph.in/text.asp?2020/64/5/22/282413
| Introduction|| |
The level and trend of HIV in India is monitored by the periodic HIV Sentinel Surveillance (HSS) among key population groups. The 15th round of HSS was conducted in 2017, wherein four high-risk groups (HRGs), namely injecting drug users, female sex workers (FSW), men who have sex with men (MSM), and hijra/transgender, were included. As per the HSS 2017, the estimated HIV prevalence among MSM in India was 2.69%, whereas the estimated adult (15–49 years) HIV prevalence in general population was 0.22%.,
The objective of the HSS is to monitor the level and trend of HIV infection in a specific geographical area, within a specific population group over period of time. The consistency of the surveillance methodology is a key factor which allows a meaningful interpretation of the observed trends of HIV positivity. The HSS among MSM was started with just three sites in the year 2000, which was scaled up to 40 in 2007 and 89 in 2017. Prior to the year 2017, the sampling strategy for HSS among the HRG was consecutive sampling with unlinked-anonymous-testing (LAT) strategy. During the round of 2010–2011, random sampling was attempted at select HRG sentinel sites only. Detailed methods are available elsewhere. Post a detailed review, the following changes were made during HSS 2017: first, the sampling strategy was changed from consecutive sampling to random sampling for selecting the eligible participants, wherein the list of active group members enrolled with the targeted interventions (TIs) would comprise the sampling frame from which the random sample was drawn. The second modification was in the recruitment strategy. Out of the eligible, only those who gave written informed consent were enrolled in the HSS 2017 round. This recruitment strategy was termed as LAT with written informed consent. The objective of introducing LAT with written informed consent was to ensure that participants who tested positive for HIV could be traced back and linked to HIV care and treatment program.
We hypothesized that the change in sampling and recruitment strategies could have affected the participation rate differentially, thus leading to selection bias. This, in turn, could affect the observed HIV seropositivity rate. The objective of our study was to explore whether inclusion of informed consent is associated with HIV seropositivity rates among MSM population in the four states of Central India.
| Materials and Methods|| |
Our study was based on analysis of the data that were collected during 2017 HSS. It was supplemented along with additional program data described below. Study site: HIV sentinel sites located in the five states of India (Bihar, Delhi, Jharkhand, Uttar Pradesh, and Uttarakhand) that constituted the Central Zone of HSS were eligible to be included in the analysis. These sentinel sites were also supervised by All India Institute of Medical Sciences (AIIMS), New Delhi. Bihar state was excluded from this study due to operational reasons. The sentinel sites were located at TI facilities operated by nongovernmental organizations. Study period: The analysis was conducted in the year 2018 after the completion of the 2017 HSS round. Sample size: At each sentinel site, 250 MSM were recruited as per the prescribed methods. A brief interview schedule that included demographic information and HIV-related risk behavior was administered followed by collection of blood specimens. Sampling frame: Each TI site maintained a master list of the high-risk individuals (HRIs) who had ever been contacted and registered at that TI. This list, available in Microsoft Excel format, formed the basis for the random selection. From the respective State AIDS Control Society (SACS), each TI site received a list of 250 HRIs drawn randomly from the master list. The peer educator (PE) then made attempts to contact the selected HRI and volunteered to accompany them to visit the sentinel site. The personal details of the HRI were entered in the HSS register, and eligibility for participation in HSS was assessed. Informed written consent was sought from the eligible HRI for their participation in HSS. The HRI in the SACS list who either refused to participate when contacted by PE or could not be contacted even after three attempts was classified as “nonparticipants.” Participants were defined as all those HRIs who participated in HSS 2017 irrespective of whether they were mentioned in the random list or were selected by the TI partner even if outside of random list. Data sources for the study: For this analysis, data were obtained from three sources: (i) master list with last-known HIV test result of HRIs to abstract the information on HIV status of the nonparticipants, (ii) HSS register to determine the extent of nonparticipation, and (iii) secured website portal of the National AIDS Control Organization (NACO) (Strategic Information Management System [SIMS]) database. Quality control: Data from the physical paper-based forms were entered into the web-based software called SIMS twice by two separate data entry operators. Dual data were matched to identify mismatched entry which was resolved by referring to the original paper-based data. All HIV-positive blood samples and randomly selected 5% of the HIV-negative blood samples were sent from the respective State Reference Laboratory to the National Reference Laboratory (NRL) located at the National AIDS Research Institute, Pune. The NRL independently rechecked HIV status of the blood samples as a quality-control mechanism under the External Quality Assurance Scheme. All data forms with HIV-positive result were cross-checked with the data entered in the online system as part of quality check. Statistical methods: After merging and matching the data, statistical analysis was done using STATA-12 software (StataCorp. 2011. Stata Statistical Software: Release 12. College Station, TX: StataCorp LP). The Chi-square test was used to compare the two groups. Regional Institutes for HIV Surveillance are mandated to carry out epidemiological investigations periodically as a part of maintaining the highest quality of surveillance data and to help optimal interpretation of the findings of surveillance. NACO has permitted to use the surveillance data. Hence, ethical clearance was not required.
| Results|| |
A total of nine MSM sites from the four states of Delhi (2), Jharkhand (1), Uttarakhand (1), and Uttar Pradesh (5) were included in the analysis. Overall nonparticipation rate was 14.7%. It was highest for Jharkhand (26.0%) followed by Delhi (24.4%) and Uttar Pradesh (10.2%). Uttarakhand had the lowest nonparticipation rate (6.8%) among the four states [Table 1].
|Table 1: State-wise distribution of participants and non-participants in men having sex with men group during HIV Sentinel Surveillance 2017|
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[Table 2] shows the comparison of HIV positivity rate among participants and nonparticipants. Overall, the HIV positivity rate among nonparticipants was higher (4.2%) compared to participants (1.4%). This difference was statistically significant (P < 0.001). The HIV positivity rate was higher among nonparticipants when compared to participants in all the three states except Jharkhand. In Uttar Pradesh, the HIV positivity rate among nonparticipants was statistically significantly higher (7.09) than that of participants (1.12) (P < 0.001). Similarly, in Uttarakhand, the HIV positivity rate was much higher at 11.8% among the participants compared to 2.8% among the nonparticipants [Table 2].
|Table 2: HIV positivity rate among participants and non-participants in men having sex with men group during HIV Sentinel Surveillance 2019|
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| Discussion|| |
During the 15th round of HSS, the sampling strategy was changed from consecutive sampling with unlinked anonymous testing to random sampling with LAT. The recruitment of participants was conditioned to their written informed consent. In this study, we aimed to find whether this change in strategy, especially seeking written informed consent before participation in the study, had any effect on the observed HIV positivity rates among the MSM of the states of Delhi, Jharkhand, Uttarakhand, and Uttar Pradesh. We present a comparison of HIV positivity rate between participants and nonparticipants of the sentinel surveillance for HIV among MSM in four northern states of India. We showed that the HIV positivity rate among nonparticipants was higher compared to participants.
The nonparticipation rate varied greatly between the states. The nonparticipation rate among MSM was highest for Jharkhand (26.0%) followed by Delhi (24.4%), whereas it was lowest in Uttarakhand (6.8%). The most plausible reason for nonparticipation could be that those MSM who knew that they were HIV positive were less inclined to get tested again for HIV. The assertion is supported by our second observation that the HIV positivity rate among nonparticipants was always higher than the participants in three out of the four states [Table 2]. Thus, there was a selective refusal by HRIs who were already aware of their HIV-positive status. These HIV-positive HRIs may not have perceived any added benefit by participating in the current round of HSS. Such selective refusal (nonparticipation) of HIV-positive HRIs had thus led to underestimation of the overall HIV prevalence rate leading to a case of selection bias in the current round of HSS.
The term MSM is actually used to define the sexual behavior and not the self-identity. Due to the cultural pressure and illegal status until recently, many MSM engaged in heterosexual relations and got married. Due to this, the MSM also potentially become a bridge population aiding transfer of HIV infection to the otherwise lower risk female partners. In addition, due to stigma, discrimination, and social exclusion, this population group is unable to access the preventive health-care services, especially the testing and counseling services, further jeopardizing their risk to HIV infection. Hitherto, using the previous strategy of unlinked anonymous testing, linking an individual who came reactive was not possible, and hence, leaving out a HIV-positive person out of care and treatment was an ethical dilemma for the National HIV Program, especially given the availability of highly active antiretroviral therapy. These revisions in HSS methodologies were adopted in the five states of Central India that were supervised by the Regional Institute AIIMS, New Delhi, in round 2017.
The purpose of HSS is to monitor the level and trend of HIV in a given population so that the required public health response is evidence based. In the era of human rights and ethical conduct, it is also an imperative that those testing HIV positive must be informed and offered timely antiretroviral therapy as per the existing guidelines. The underlying principle for change in sampling and recruitment strategy was to obtain more representative data and do so in an ethical manner. However, we found a significant nonparticipation which could virtually rule out the representativeness of the sample. The nonparticipation seemed to be influenced by HIV-positive status which led to selection bias. We showed that this selection bias ultimately led to underestimation of the HIV positivity rate among MSM in the four Central Zone states from where data for this analysis were sourced.
Current ethical and legal requirements mandate that HIV testing can be done only after written informed consent and assurance that care and support would be provided to those who test HIV positive. We have shown that HSS in its current form would lead to underestimation of prevalence rate and this could result in complacency. The other alternative to track that HIV epidemic among HRI could be case reporting which is an acceptable method of HIV surveillance. As per the NACO guidelines, the TI sites perform a 6-monthly HIV testing for all the individuals enrolled with them, and those who test positive are linked to the care and treatment program. With almost 65% coverage among MSM and also FSW, the TI sites provide a ripe opportunity to implement HIV case reporting as a surveillance method.
The findings of our study are based on data from four states of Central Zone, which is a limiting factor. A similar analysis from other zones and other population groups would help triangulate our results. The assessment was done quantitatively which can now be used for comparison in the future. Due to the logistic reasons, Bihar state was excluded impacting the completeness of assessment for Central Zone as one unit. The HIV status in participants and nonparticipants was measured by different ways.
In participants, the HIV status was checked during the recruitment of the study, and in case of nonparticipants, the status was verified from the records at TI. However, the same testing strategy was used in both the groups, and it is unlikely that there will be a difference in the quality of data. Hence, results are comparable in both the groups. There could be a possibility of other factors affecting the association. However, we were unable to identify any such factor.
| Conclusion|| |
Differential participation rate based on known HIV status poses a serious challenge to the representativeness of the observed finding. The change in sampling strategy and introduction of written informed consent for recruitment of HRGs in HSS 2017 round could have led to an underestimation of HIV seropositivity rate among MSM in Central Zone.
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Conflicts of interest
There are no conflicts of interest.
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