Predictors of hepatitis C cure among people who inject drugs treated with directly observed therapy supported by peer case managers in Kenya.

BACKGROUND & AIMS: Directly observed therapy (DOT) maximizes adherence and minimizes treatment gaps. Peer case managers (PCM) have also shown promise as a component of integrated HCV treatment strategies. DOT and PCM-support have been underexplored, particularly in low- and middle-income countries (LMICs). The objective of this study was to evaluate predictors of sustained virologic response (SVR) among people who inject drugs (PWID) attending medication-assisted treatment (MAT) and needle and syringe programs (NSP) sites in Kenya. METHODS: We recruited PWID accessing MAT and NSP in Nairobi and Coastal Kenya. PWID were treated with ledipasvir/sofosbuvir using DOT supported by PCMs. We used bivariate and multivariate logistic regression to examine the impact of sociodemographic, behavioral, and clinical factors on SVR. RESULTS: Among 92 PWID who initiated HCV treatment, 79 (86%) were male with mean age of 36.3 years (SD=±6.5); 38 (41%) were HIV-positive, and 87 (95%) reported injecting drugs in the last 30 days. Just over half of participants were genotype 1a (55%), followed by genotype 4a (41%) and mixed 1a/4a (3%). Most participants, 85 (92%) completed treatment and 79 (86%) achieved SVR. While sociodemographic and behavioral factors including recent injection drug use were not significantly associated with achieving SVR, being fully adherent (p=0.042), number of doses taken (p=0.008) and treatment completion (p= 0.001) were associated with higher odds of achieving SVR. CONCLUSIONS: DOT with PCM-support was an effective model for HCV treatment among PWID in this LMIC setting. Adherence was the most important driver of SVR suggesting DOT and PCM support can overcome other factors that might limit adherence. Further research is necessary to ascertain the effectiveness of other models of HCV care for PWID in LMICs given NSP and MAT access is variable, and DOT may not be sustainable with limited resources.

Modelling the impact of HIV and hepatitis C virus prevention and treatment interventions among people who inject drugs in Kenya.

OBJECTIVES: People who inject drugs (PWID) in Kenya have high HIV (range across settings: 14-26%) and hepatitis C virus (HCV; 11-36%) prevalence. We evaluated the impact of existing and scaled-up interventions on HIV and HCV incidence among PWID in Kenya. DESIGN: HIV and HCV transmission model among PWID, calibrated to Nairobi and Kenya's Coastal region. METHODS: For each setting, we projected the impact (percent of HIV/HCV infections averted in 2020) of existing coverages of antiretroviral therapy (ART; 63-79%), opioid agonist therapy (OAT; 8-13%) and needle and syringe programmes (NSP; 45-61%). We then projected the impact (reduction in HIV/HCV incidence over 2021-2030), of scaling-up harm reduction [Full harm reduction ('Full HR'): 50% OAT, 75% NSP] and/or HIV (UNAIDS 90-90-90) and HCV treatment (1000 PWID over 2021-2025) and reducing sexual risk (by 25/50/75%). We estimated HCV treatment levels needed to reduce HCV incidence by 90% by 2030. RESULTS: In 2020, OAT and NSP averted 46.0-50.8% (range of medians) of HIV infections and 50.0-66.1% of HCV infections, mostly because of NSP. ART only averted 12.9-39.8% of HIV infections because of suboptimal viral suppression (28-48%). Full HR and ART could reduce HIV incidence by 51.5-64% and HCV incidence by 84.6-86.6% by 2030. Also halving sexual risk could reduce HIV incidence by 68.0-74.1%. Alongside full HR, treating 2244 PWID over 2021-2025 could reduce HCV incidence by 90% by 2030. CONCLUSION: Existing interventions are having substantial impact on HIV and HCV transmission in Kenya. However, to eliminate HIV and HCV, further scale-up is needed with reductions in sexual risk and HCV treatment.

Challenges and best practices for hepatitis C care among people who inject drugs in resource limited settings: focus group discussions with healthcare providers in Kenya.

People who inject drugs (PWID) living with Hepatitis C (HCV) in low- and middle-income countries face substantial barriers to HCV care. We sought to gain healthcare providers' perspectives on challenges and best practices for HCV care provision among PWID in Kenya. We conducted three focus group discussions (FGD) with 23 healthcare providers working with PWID living with HCV in Nairobi and Mombasa. Transcribed interviews were analysed thematically. Overarching themes regarding HCV prevention and treatment were: (1) lack of HCV-related knowledge at the provider and patient levels; (2) stigmatisation of people living with HCV and PWID; and (3) difficulties among PWID with navigating the healthcare system. Some providers suggested systematically integrating HCV care into existing PWID-specific harm reduction programs to improve HCV care provision as well as creating national HCV guidelines to guide clinicians. This study highlights the need for national HCV treatment guidelines and increased public HCV education, as well as culturally sensitive models integrating HCV care into programs PWID are already accessing. These strategies will be useful in improving access to HCV care among PWID and has the potential to decrease HCV transmission and prevalence among this vulnerable population.

Hepatitis C-related knowledge, attitudes and perceived risk behaviours among people who inject drugs in Kenya: A qualitative study.

Despite disproportionately high rates of Hepatitis C (HCV) among people who inject drugs (PWID) in low- and middle-income countries (LMICs), understanding of HCV-related knowledge, attitudes and perceived risk behaviours among this population remains limited. We aimed to elucidate knowledge, attitudes and experiences that could minimise transmission risk and maximise HCV treatment engagement among PWID in Kenya following the integration of HCV screening and education with needle and syringe programmes in drop-in-centres (DICs). We recruited 40 PWID with chronic HCV attending DICs in Nairobi and Coastal Kenya. Semi-structured interviews revealed a general understanding of HCV and awareness of HCV risk behaviours among participants; however, many felt limited control over their transmission risk due to factors such as 'local doctors', or individuals who perform a high volume of high-risk injections. Financial barriers, distance to clinic, poor health status and HCV-related stigma were all noted as barriers to HCV treatment. In conclusion, basic knowledge of and motivation for HCV treatment among PWID accessing DICs in Kenya was high; however, structural barriers and stigma complicate access to care. Local education programmes can address knowledge gaps, and behavioural and structural interventions can maximise the impact of HCV care in LMICs.

An intensive model of care for hepatitis C virus screening and treatment with direct-acting antivirals in people who inject drugs in Nairobi, Kenya: a model-based cost-effectiveness analysis.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) treatment is essential for eliminating HCV in people who inject drugs (PWID), but has limited coverage in resource-limited settings. We measured the cost-effectiveness of a pilot HCV screening and treatment intervention using directly observed therapy among PWID attending harm reduction services in Nairobi, Kenya. DESIGN: We utilized an existing model of HIV and HCV transmission among current and former PWID in Nairobi to estimate the cost-effectiveness of screening and treatment for HCV, including prevention benefits versus no screening and treatment. The cure rate of treatment and costs for screening and treatment were estimated from intervention data, while other model parameters were derived from literature. Cost-effectiveness was evaluated over a life-time horizon from the health-care provider's perspective. One-way and probabilistic sensitivity analyses were performed. SETTING: Nairobi, Kenya. POPULATION: PWID. MEASUREMENTS: Treatment costs, incremental cost-effectiveness ratio (cost per disability-adjusted life year averted). FINDINGS: The cost per disability-adjusted life-year averted for the intervention was $975, with 92.1% of the probabilistic sensitivity analyses simulations falling below the per capita gross domestic product for Kenya ($1509; commonly used as a suitable threshold for determining whether an intervention is cost-effective). However, the intervention was not cost-effective at the opportunity cost-based cost-effectiveness threshold of $647 per disability-adjusted life-year averted. Sensitivity analyses showed that the intervention could provide more value for money by including modelled estimates for HCV disease care costs, assuming lower drug prices ($75 instead of $728 per course) and excluding directly-observed therapy costs. CONCLUSIONS: The current strategy of screening and treatment for hepatitis C virus (HCV) among people who inject drugs in Nairobi is likely to be highly cost-effective with currently available cheaper drug prices, if directly-observed therapy is not used and HCV disease care costs are accounted for.

Computer-Based Counseling Program (CARE+ Kenya) to Promote Prevention and HIV Health for People Living With HIV/AIDS: A Randomized Controlled Trial.

In countries experiencing the dual burden of HIV disease and health care worker shortages, information and communication technology tools offer the potential to help support HIV treatment adherence and secondary HIV transmission risk reduction for people living with HIV/AIDS. We conducted a randomized controlled trial (September 1, 2011-July 12, 2012) with follow-up through April 2013. Participants were recruited from two clinics affiliated with the Academic Model Providing Access to Healthcare program in western Kenya. A total of 236 participants were enrolled, randomly assigned to intervention (n = 118) or risk-assessment only control (n = 118) and followed up for 9 months. Both arms had > 0.5 log10 reduction in viral load over time (p = .0007), a clinically relevant finding. A computer-based counseling tool is feasible and acceptable in a high-volume East African HIV setting and provides evidence-based ART adherence and risk reduction support that may extend health workforce deficits.

Prevalence, estimated incidence, risk behaviours, and genotypic distribution of hepatitis C virus among people who inject drugs accessing harm-reduction services in Kenya: a retrospective cohort study.

BACKGROUND: Sub-Saharan Africa has a large population of people with hepatitis C virus (HCV) infection, yet little is known about HCV among people who inject drugs this region. We assessed the prevalence of HCV mono-infection and HIV-HCV co-infection, and the estimated incidence, genotypes, and risk behaviours associated with HCV among people who inject drugs in Kenya. METHODS: People aged 18 years or older who were living in Nairobi, coastal Kenya, or western Kenya, had a history of injection drug use, and had used any illicit drugs in the past 12 months were recruited at needle and syringe programme sites using respondent-driven sampling. Participants were screened for the presence of an anti-HCV antibody. Those who were anti-HCV positive underwent confirmatory HCV RNA testing, and those with detectable HCV RNA were genotyped. Participants were interviewed regarding parenteral risk behaviours and exposure to services received at the needle and syringe programme sites. We examined correlates of HCV infection and HIV-HCV co-infection using bivariate and multivariate regression, and estimated HCV incidence. FINDINGS: Of 2188 enrolled participants, 291 (13%) were anti-HCV positive: 183 (22%) of 842 participants in coastal Kenya, 105 (13%) of 817 in Nairobi, and three (1%) of 529 in western Kenya. 284 anti-HCV-positive participants underwent successful HCV RNA testing, of whom 230 (81%) were viraemic. Estimated incidence rates of anti-HCV positivity per 100 person-years were 6·31 in coastal Kenya, 3·19 in Nairobi, and 0·22 in western Kenya. HCV incidence rate was greater in coastal Kenya compared with Nairobi (incidence rate ratio 1·97 [95% CI 1·35-2·93], p=0·0001) and the western region (28·17 [7·55-236·58], p<0·0001). In the coastal region, history of incarceration, more years injecting, more injections in the past month, and receptive cooker sharing were associated with increased risk of HCV, while female sex, more years injecting, more injections in the past month, and regular use of a syringe with a detachable needle were associated with HCV risk in Nairobi. HCV prevalence among HIV-positive participants was 50% (66 of 131 participants) in coastal Kenya, 35% (42 of 121) in Nairobi, and 4% (one of 23) in western Kenya. Risk factors for HIV-HCV co-infection were similar to those observed for HCV mono-infection. The prevailing genotypes were 1a (51%), 4a (47%), and mixed (2%; three 1a/4a and one 1a/2b). INTERPRETATION: HCV prevalence, estimated incidence, and risk behaviours among people who inject drugs in Kenya vary with region, with the highest estimated incidence observed in coastal Kenya. These findings should be used to inform focused strategies to reduce HCV transmission, such as expansion of needle and syringe programmes, upscaling of opioid agonist therapy, and treatment as prevention in regions affected by injection drug use and HCV. FUNDING: National Institute on Drug Abuse.

Linguistic and Cultural Adaptation of a Computer-Based Counseling Program (CARE+ Spanish) to Support HIV Treatment Adherence and Risk Reduction for People Living With HIV/AIDS: A Randomized Controlled Trial.

BACKGROUND: Human immunodeficiency virus (HIV) disease in the United States disproportionately affects minorities, including Latinos. Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos, yet ART and interventions for clinic visit adherence are rarely developed or delivered in Spanish. OBJECTIVE: The aim was to adapt a computer-based counseling tool, demonstrated to reduce HIV-1 viral load and sexual risk transmission in a population of English-speaking adults, for use during routine clinical visits for an HIV-positive Spanish-speaking population (CARE+ Spanish); the Technology Acceptance Model (TAM) was the theoretical framework guiding program development. METHODS: A longitudinal randomized controlled trial was conducted from June 4, 2010 to March 29, 2012. Participants were recruited from a comprehensive HIV treatment center comprising three clinics in New York City. Eligibility criteria were (1) adults (age ≥18 years), (2) Latino birth or ancestry, (3) speaks Spanish (mono- or multilingual), and (4) on antiretrovirals. Linear and generalized mixed linear effects models were used to analyze primary outcomes, which included ART adherence, sexual transmission risk behaviors, and HIV-1 viral loads. Exit interviews were offered to purposively selected intervention participants to explore cultural acceptability of the tool among participants, and focus groups explored the acceptability and system efficiency issues among clinic providers, using the TAM framework. RESULTS: A total of 494 Spanish-speaking HIV clinic attendees were enrolled and randomly assigned to the intervention (arm A: n=253) or risk assessment-only control (arm B, n=241) group and followed up at 3-month intervals for one year. Gender distribution was 296 (68.4%) male, 110 (25.4%) female, and 10 (2.3%) transgender. By study end, 433 of 494 (87.7%) participants were retained. Although intervention participants had reduced viral loads, increased ART adherence and decreased sexual transmission risk behaviors over time, these findings were not statistically significant. We also conducted 61 qualitative exit interviews with participants and two focus groups with a total of 16 providers. CONCLUSIONS: A computer-based counseling tool grounded in the TAM theoretical model and delivered in Spanish was acceptable and feasible to implement in a high-volume HIV clinic setting. It was able to provide evidence-based, linguistically appropriate ART adherence support without requiring additional staff time, bilingual status, or translation services. We found that language preferences and cultural acceptability of a computer-based counseling tool exist on a continuum in our urban Spanish-speaking population. Theoretical frameworks of technology's usefulness for behavioral modification need further exploration in other languages and cultures. TRIAL REGISTRATION: ClinicalTrials.gov NCT01013935; https://clinicaltrials.gov/ct2/show/NCT01013935 (Archived by WebCite at http://www.webcitation.org/6ikaD3MT7).

HIV Prevalence, Estimated Incidence, and Risk Behaviors Among People Who Inject Drugs in Kenya.

OBJECTIVE: HIV infection in sub-Saharan Africa increasingly occurs among people who inject drugs (PWID). Kenya is one of the first to implement a national needle and syringe program. Our study undertook a baseline assessment as part of evaluating needle and syringe program in a seek, test, treat, and retain approach. METHODS: Participants enrolled between May and December 2012 from 10 sites. Respondent-driven sampling was used to reach 1785 PWID for HIV-1 prevalence and viral load determination and survey data. RESULTS: Estimated HIV prevalence, adjusted for differential network size and recruitment relationships, was 14.5% in Nairobi (95% CI: 10.8 to 18.2) and 20.5% in the Coast region (95% CI: 17.3 to 23.6). Viral load (log10 transformed) in Nairobi ranged from 1.71 to 6.12 (median: 4.41; interquartile range: 3.51-4.94) and in the Coast from 1.71 to 5.88 (median: 4.01; interquartile range: 3.44-4.72). Using log10 viral load 2.6 as a threshold for HIV viral suppression, the percentage of HIV-infected participants with viral suppression was 4.2% in Nairobi and 4.6% in the Coast. Heroin was the most commonly injected drug in both regions, used by 93% of participants in the past month, typically injecting 2-3 times/day. Receptive needle/syringe sharing at last injection was more common in Nairobi (23%) than in the Coast (4%). Estimated incidence among new injectors was 2.5/100 person-years in Nairobi and 1.6/100 person-years in the Coast. CONCLUSIONS: The HIV epidemic is well established among PWID in both Nairobi and Coast regions. Public health scale implementation of combination HIV prevention has the potential to greatly limit the epidemic in this vulnerable and bridging population.

Implementation and Operational Research: A Time-Motion Analysis of HIV Transmission Prevention Counseling and Antiretroviral Adherence Messages in Western Kenya.

BACKGROUND: Shortages of health workers and large number of HIV-infected persons in Africa mean that time to provide antiretroviral therapy (ART) adherence and other messages to patients is limited. METHODS: Using time-motion methodology, we documented the intensity and nature of counseling delivered to patients. The study was conducted at a rural and an urban HIV clinic in western Kenya. We recorded all activities of 190 adult patients on ART during their return clinic visits to assess type, frequency, and duration of counseling messages. RESULTS: Mean visit length for patients at the rural clinic was 44.5 (SD = 27.9) minutes and at urban clinic was 78.2 (SD = 42.1) minutes. Median time spent receiving any counseling during a visit was 4.07 minutes [interquartile range (IQR), 1.57-7.33] at rural and 3.99 (IQR, 2.87-6.25) minutes at urban, representing 11% and 8% of total mean visit time, respectively. Median time patients received ART adherence counseling was 1.29 (IQR, 0.77-2.83) minutes at rural and 1.76 (IQR, 1.23-2.83) minutes at urban (P = 0.001 for difference). Patients received a median time of 0.18 (0-0.72) minutes at rural and 0.28 (IQR, 0-0.67) minutes at urban clinic of counseling regarding contraception and pregnancy. Most patients in the study did not receive any counseling regarding alcohol/substance use, emerging risks for ongoing HIV transmission. CONCLUSIONS: Although ART adherence was discussed with most patients, time was limited. Reproductive counseling was provided to only half of the patients, and "positive prevention" messaging was minimal. There are strategic opportunities to enhance counseling and information received by clients within HIV programs in resource-limited settings.