ASSESSMENT OF THE BEHAVIORAL INTERVENTION “STEPS TOWARDS HEALTH” FOR HIV-POSITIVE PERSONS WHO INJECT DRUGS IN UKRAINE Tetiana Kiriazova 1 , Yuliia Sereda 1 , Roman Yorick 2 , Inna Shvab 2 , Sergii Dvoriak 1 1 Ukrainian Institute on Public Health Policy (UIPHP), Kyiv, Ukraine, 2 USAID RESPOND Project, Pact Inc., Kyiv, Ukraine Ukrainian Institute on Public Health Policy: uiphp.org.ua, e-mail: [email protected] USAID RESPOND Project: www.respond.org.ua, [email protected] BACKGROUND People who inject drugs (PWID) have the highest HIV prevalence and incidence in Ukraine; in 2015, HIV prevalence among PWID increased to 21.9% compared to 19.7% in 2013 1 . However, globally, HIV-in- fected PWID demonstrate signi�icant losses across HIV care cascade 2 . In Ukraine, 1/3 of HIV-positive individuals who know their status remain outside HIV care 3 . This study assessed whether behavioral intervention “Steps towards Health” was superior than the standard of service for re-engaging HIV-infected PWID with medical care and treatment 1 Barska J., Sazonova J. et al. Monitoring of behavior and HIV prevalence among people who use drugs and their sexual partners. Alliance of Public Health, Kyiv, 2016, 130 pp. 2 Mann, B., et al. Improved adherence to modern antiretroviral therapy among HIV-infected injecting drug users. HIV medicine, 2012. 13(10): p. 596-601. 3 HIV infection in Ukraine. Informational Bulletin # 45. Ministry of Health of Ukraine, 2016. Fig.1. Cities of Ukraine with the “Steps towards Health” intervention sites. METHODS Study Design: Randomized control trial. Inclusion criteria 18+ years of age; con�irmed HIV+ status and registration at AIDS center; no visits to the AIDS center within past 6 months; not on ART during past 6 months; reported injection drug use (IDU) during past 6 months; able to provide 2 alternative contacts; able to provide informed consent to participate in the study. After screening, HIV+ PWID from two cities in Ukraine were randomly assigned to receive either intervention “Steps towards Health” (intervention group – IG) or standard of services provided by local NGOs (control group – CG), 150 participants in each group. Intervention Behavioral intervention “Steps towards Health” was designed in Ukraine by the USAID RESPOND Proj- ect in March, 2015 in partnership with the All-Ukrainian Network of People Living with HIV, and was implemented by HIV-servicing NGOs in 2 regions of Ukraine (Fig. 1). It consists of introductory and 5 individual counseling sessions within 3-month period with case-management component, for target- ing HIV-positive PWID, registered at AIDS Centers but missing follow-up visits for minimum 6 months, to improve their engagement with HIV care. Standard of services Control group received a standard service package from NGOs (syringe exchange, free condoms / lubri- cants, social worker / psychologist counselling on request); no sessions on behavior change or case-man- agement. Data collection Data was collected in March 2015 - November 2016 at 2 local NGOs in Melitopol, Zaporizhzhia Region, and Kryvy Rih, Dnipro Region (Fig.1) using Audio Computer-Assisted Self-Interview Software (ACA- SI) at baseline, 3- and 6-month follow-up by trained independent interviewers. Interview included questions on participant socio-demographics, sexual behavior, drug use, and adherence to HIV medi- cal services. After each interview, all participants received cards equivalent to 8 USD to purchase food or household chemicals. Randomized (n=300) Assessed for eligibility (n=318) Excluded (n=18) • Declined to parcipate (n=18) Lost to follow-up (n=1) • Died (n=1) Lost to follow-up (n=0) • 1 person was back to follow-up Allocated to control (n=150) Enrollment 6-month follow-up (N=282) Allocated to intervenon (n=150) • Received allocated intervenon (n=150) Allocaon Lost to follow-up (n=8) • Died (n=2) • Incarcerated (n=3) • Hospitalized in closed sengs (n=2) • Moved away from study site (n=1) Lost to follow-up (n=10) • Died (n=6) • Hospitalized in closed sengs (n=2) • Contact tracing was unsuccessful (n=2) 3-month follow-up (N=282) Fig.2. Flow chart of study participants, two Ukrainian cities, 2016. RESULTS We invited 318 PWID to participate in the study (Figure 2); 300 (94%) individuals met inclusion criteria, provided informed consent and were randomized 1:1 to IG or CG. Retention rate was 95% in IG and 93% in CG at 3-month follow-up, and 94% in each group at 6-month follow-up. Ninety-four percent of IG participants received all 5 sessions; all sessions included intervention key elements. In intention to treat analysis, IG participants were 1.6 times more likely to visit ID physician (RR = 1.60 , 95% CI: 1.34-1.91), 1.6 times more likely to have CD4 test (RR = 1.60, 95% CI: 1.33-1.93), and twice more likely to start ART (RR = 2.11, 95% CI: 1.27-3.52) than CG participants (Table 2). Despite intervention effect for clinical outcomes, signi�i- cant gaps in the HIV care cascade were discovered in both groups (Fig.3). CONCLUSIONS Behavioral intervention “Steps towards Health” was found effective in re-engaging HIV-positive PWID who dropped out of HIV care. Given the evidence of its feasibility and effectiveness, the intervention can be recommended for further dissemination in Ukraine. Further efforts are needed to assess the inter- vention effects in a longer perspective (over 6 months). Table 1. Baseline characteristics of participants by assignment. n Intervenon (N=150) Control (N=150) Total (N=300) p-value % n % n % City Kryviy Rig 75 50% 75 50% 150 50% 1.000 Melitopol 75 50% 75 50% 150 50% Age, mean (SD), years 39 (7) 38 (8) 39 (7) 0.498 Gender Males 98 65% 91 61% 189 63% 0.403 Females 52 35% 59 39% 111 37% Educaon Primary 19 13% 17 11% 36 12% 0.523 Secondary 40 27% 39 26% 79 26% Vocaonal 83 55% 82 55% 165 55% University degree 8 5% 11 8% 19 7% Marital status Registered marriage 17 11% 27 18% 44 15% 0.114 Cohabing couple 46 31% 45 30% 91 30% Non-cohabing couple 6 4% 12 8% 18 6% Single 79 53% 66 44% 145 48% Missing 2 1% 0 0% 2 1% History of incarceraon Yes 78 52% 81 54% 159 53% 0.729 No 72 48% 69 46% 141 47% * SD = standard deviation; UAH = Ukrainian hryvnas (1 USD = 26 UAH) Intervention arm 150 150 115 38 100% 100% 77% 25% Control arm 150 150 72 18 100% 100% 48% 12% Total number of PLHIV-PWID Registered in the AIDS center* Acve enrollment in care On ART Fig.3. HIV care cascade among study participants: 6-month assessment. Table 2. Relative risks for outcomes by assignment and duration of follow up. 3-month follow-up 6-month follow-up Intervenon Control RR (95% CI) Intervenon Control RR (95% CI) n/N (%) n/N (%) n/N (%) n/N (%) Visited an Infecous Disease Specialist at least once aſt er enrollment in the study (ref.: no visit) 105/140 (75%) 65/142 (46%) 1.64 (1.34-2.01) 115/141 (82%) 72/141 (51%) 1.60 (1.34-1.91) Had CD4 test at least once aſt er enrollment in the study (ref.: no CD4 test)* - - - 112/141 (79%) 70/141 (50%) 1.60 (1.33-1.93) Started ART (ref.: no ART) - - - 38/141 (27%) 18/141 (13%) 2.11 (1.27-3.52) RR = relative risk, CI = con�idence interval, ref. = reference group. * CD4 test and ART was limited at AIDS centers during 3-month follow-up. Primary outcomes of interest Re-engagement with HIV care: at least one visit to an ID physician at AIDS Center after enrollment in the study; at least one CD4 test after enrollment in the study; start or return to ART. Data analysis Intent-to-treat analysis compared IG and CG at each assessment. Differences in socio-demographic char- acteristics and selected outcomes between groups were examined using chi-square tests and T-tests. To assess the Missing at Random (MAR), we performed bivariate analysis of missing data. No signi�icant differences at 5% level between IG and CG were found for the proportion of missing participants at 3- and 6-months follow-up. Outcomes were modeled by binary log-binomial regressions. Relative risks (RR) and 95% con�idence intervals were calculated to measure Intervention effect.
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
ASSESSMENT OF THE BEHAVIORAL INTERVENTION “STEPS TOWARDS HEALTH” FOR HIV-POSITIVE PERSONS WHO INJECT DRUGS IN UKRAINE
Tetiana Kiriazova1, Yuliia Sereda1, Roman Yorick2, Inna Shvab2, Sergii Dvoriak1
1Ukrainian Institute on Public Health Policy (UIPHP), Kyiv, Ukraine, 2USAID RESPOND Project, Pact Inc., Kyiv, Ukraine
Ukrainian Institute on Public Health Policy: uiphp.org.ua, e-mail: [email protected]
USAID RESPOND Project: www.respond.org.ua, [email protected]
BACKGROUNDPeople who inject drugs (PWID) have the highest HIV prevalence and incidence in Ukraine; in 2015, HIV prevalence among PWID increased to 21.9% compared to 19.7% in 20131. However, globally, HIV-in-fected PWID demonstrate signi�icant losses across HIV care cascade2. In Ukraine, 1/3 of HIV-positive individuals who know their status remain outside HIV care3.This study assessed whether behavioral intervention “Steps towards Health” was superior than the standard of service for re-engaging HIV-infected PWID with medical care and treatment 1 Barska J., Sazonova J. et al. Monitoring of behavior and HIV prevalence among people who use drugs and their sexual partners. Alliance of Public Health, Kyiv, 2016, 130 pp.2 Mann, B., et al. Improved adherence to modern antiretroviral therapy among HIV-infected injecting drug users. HIV medicine, 2012. 13(10): p. 596-601.3 HIV infection in Ukraine. Informational Bulletin # 45. Ministry of Health of Ukraine, 2016.
Fig.1. Cities of Ukraine with the “Steps towards Health” intervention sites.
METHODS
Study Design:
Randomized control trial.
Inclusion criteria
18+ years of age; con�irmed HIV+ status and registration at AIDS center; no visits to the AIDS center within past 6 months; not on ART during past 6 months; reported injection drug use (IDU) during past 6 months; able to provide 2 alternative contacts; able to provide informed consent to participate in the study. After screening, HIV+ PWID from two cities in Ukraine were randomly assigned to receive either intervention “Steps towards Health” (intervention group – IG) or standard of services provided by local NGOs (control group – CG), 150 participants in each group.
Intervention
Behavioral intervention “Steps towards Health” was designed in Ukraine by the USAID RESPOND Proj-ect in March, 2015 in partnership with the All-Ukrainian Network of People Living with HIV, and was implemented by HIV-servicing NGOs in 2 regions of Ukraine (Fig. 1). It consists of introductory and 5 individual counseling sessions within 3-month period with case-management component, for target-ing HIV-positive PWID, registered at AIDS Centers but missing follow-up visits for minimum 6 months, to improve their engagement with HIV care.
Standard of services
Control group received a standard service package from NGOs (syringe exchange, free condoms / lubri-cants, social worker / psychologist counselling on request); no sessions on behavior change or case-man-agement.
Data collection
Data was collected in March 2015 - November 2016 at 2 local NGOs in Melitopol, Zaporizhzhia Region, and Kryvy Rih, Dnipro Region (Fig.1) using Audio Computer-Assisted Self-Interview Software (ACA-SI) at baseline, 3- and 6-month follow-up by trained independent interviewers. Interview included questions on participant socio-demographics, sexual behavior, drug use, and adherence to HIV medi-cal services. After each interview, all participants received cards equivalent to 8 USD to purchase food or household chemicals.
Randomized (n=300)
Assessed for eligibility (n=318)
Excluded (n=18)• Declined to par�cipate (n=18)
Lost to follow-up (n=1)• Died (n=1)
Lost to follow-up (n=0)• 1 person was back to follow-up
Allocated to control (n=150)
Enrollment
6-month follow-up (N=282)
Allocated to interven�on (n=150)• Received allocated interven�on (n=150)
Alloca�on
Lost to follow-up (n=8)• Died (n=2)• Incarcerated (n=3)• Hospitalized in closed se�ngs (n=2)• Moved away from study site (n=1)
Lost to follow-up (n=10)• Died (n=6)• Hospitalized in closed
se�ngs (n=2)• Contact tracing was
unsuccessful (n=2)
3-month follow-up (N=282)
Fig.2. Flow chart of study participants, two Ukrainian cities, 2016.
RESULTS
We invited 318 PWID to participate in the study (Figure 2); 300 (94%) individuals met inclusion criteria, provided informed consent and were randomized 1:1 to IG or CG. Retention rate was 95% in IG and 93% in CG at 3-month follow-up, and 94% in each group at 6-month follow-up. Ninety-four percent of IG participants received all 5 sessions; all sessions included intervention key elements.
In intention to treat analysis, IG participants were 1.6 times more likely to visit ID physician (RR = 1.60 , 95% CI: 1.34-1.91), 1.6 times more likely to have CD4 test (RR = 1.60, 95% CI: 1.33-1.93), and twice more likely to start ART (RR = 2.11, 95% CI: 1.27-3.52) than CG participants (Table 2). Despite intervention effect for clinical outcomes, signi�i-cant gaps in the HIV care cascade were discovered in both groups (Fig.3).
CONCLUSIONSBehavioral intervention “Steps towards Health” was found effective in re-engaging HIV-positive PWID who dropped out of HIV care. Given the evidence of its feasibility and effectiveness, the intervention can be recommended for further dissemination in Ukraine. Further efforts are needed to assess the inter-vention effects in a longer perspective (over 6 months).
Table 1. Baseline characteristics of participants by assignment.
n Interventi on (N=150) Control (N=150)
Total (N=300) p-value
% n % n %
City Kryviy Rig 75 50% 75 50% 150 50% 1.000Melitopol 75 50% 75 50% 150 50%Age, mean (SD), years 39 (7) 38 (8) 39 (7) 0.498
Gender Males 98 65% 91 61% 189 63% 0.403Females 52 35% 59 39% 111 37%
Educati on
Primary 19 13% 17 11% 36 12%
0.523Secondary 40 27% 39 26% 79 26%Vocati onal 83 55% 82 55% 165 55%University degree 8 5% 11 8% 19 7%
Marital status
Registered marriage 17 11% 27 18% 44 15%
0.114Cohabiti ng couple 46 31% 45 30% 91 30%Non-cohabiti ng couple 6 4% 12 8% 18 6%Single 79 53% 66 44% 145 48%Missing 2 1% 0 0% 2 1%
History of incarcerati on Yes 78 52% 81 54% 159 53%
0.729No 72 48% 69 46% 141 47%
* SD = standard deviation; UAH = Ukrainian hryvnas (1 USD = 26 UAH)
Intervention arm
150 150 115 38
100% 100% 77% 25%
Control arm
150 150 72 18
100% 100% 48% 12%
Total number of PLHIV-PWID Registered in the AIDS center* Ac�ve enrollment in care On ART
Fig.3. HIV care cascade among study participants: 6-month assessment.
Table 2. Relative risks for outcomes by assignment and duration of follow up.
3-month follow-up 6-month follow-up
Interventi on Control RR (95% CI)
Interventi on Control RR (95% CI)n/N (%) n/N (%) n/N (%) n/N (%)
Visited an Infecti ous Disease Specialist at least once aft er enrollment in the study (ref.: no visit) 105/140 (75%) 65/142 (46%) 1.64
(1.34-2.01)115/141
(82%)72/141(51%)
1.60(1.34-1.91)
Had CD4 test at least once aft er enrollment in the study (ref.: no CD4 test)* - - - 112/141 (79%) 70/141
(50%)1.60
(1.33-1.93)
Started ART (ref.: no ART) - - - 38/141(27%)
18/141(13%)
2.11(1.27-3.52)
RR = relative risk, CI = con�idence interval, ref. = reference group. * CD4 test and ART was limited at AIDS centers during 3-month follow-up.
Primary outcomes of interest
Re-engagement with HIV care: at least one visit to an ID physician at AIDS Center after enrollment in the study; at least one CD4 test after enrollment in the study; start or return to ART.
Data analysis
Intent-to-treat analysis compared IG and CG at each assessment. Differences in socio-demographic char-acteristics and selected outcomes between groups were examined using chi-square tests and T-tests. To assess the Missing at Random (MAR), we performed bivariate analysis of missing data. No signi�icant differences at 5% level between IG and CG were found for the proportion of missing participants at 3- and 6-months follow-up. Outcomes were modeled by binary log-binomial regressions. Relative risks (RR) and 95% con�idence intervals were calculated to measure Intervention effect.
Related Documents
