Uptake and effect of universal test-and-treat on twelve months retention and initial virologic suppression in routine HIV program in Kenya.

Early combination antiretroviral therapy (cART), as recommended in WHO's universal test-and-treat (UTT) policy, is associated with improved linkage to care, retention, and virologic suppression in controlled studies. We aimed to describe UTT uptake and effect on twelve-month non-retention and initial virologic non-suppression (VnS) among HIV infected adults starting cART in routine HIV program in Kenya. Individual-level HIV service delivery data from 38 health facilities, each representing 38 of the 47 counties in Kenya were analysed. Adults (>15 years) initiating cART between the second-half of 2015 (2015HY2) and the first-half of 2018 (2018HY1) were followed up for twelve months. UTT was defined based on time from an HIV diagnosis to cART initiation and was categorized as same-day, 1-14 days, 15-90 days, and 91+ days. Non-retention was defined as individuals lost-to-follow-up or reported dead by the end of the follow up period. Initial VnS was defined based on the first available viral load test with >400 copies/ml. Hierarchical mixed-effects survival and generalised linear regression models were used to assess the effect of UTT on non-retention and VnS, respectively. Of 8592 individuals analysed, majority (n = 5864 [68.2%]) were female. Same-day HIV diagnosis and cART initiation increased from 15.3% (2015HY2) to 52.2% (2018HY1). The overall non-retention rate was 2.8 (95% CI: 2.6-2.9) per 100 person-months. When compared to individuals initiated cART 91+ days after a HIV diagnosis, those initiated cART on the same day of a HIV diagnosis had the highest rate of non-retention (same-day vs. 91+ days; aHR, 1.7 [95% CI: 1.5-2.0], p<0.001). Of those included in the analysis, 5986 (69.6%) had a first viral load test done at a median of 6.3 (IQR, 5.6-7.6) months after cART initiation. Of these, 835 (13.9%) had VnS. There was no association between UTT and VnS (same-day vs. 91+ days; aRR, 1.0 [95% CI: 0.9-1.2], p = 0.664). Our findings demonstrate substantial uptake of the UTT policy but poor twelve-month retention and lack of an association with initial VnS from routine HIV settings in Kenya. These findings warrant consideration for multi-pronged program interventions alongside UTT policy for maximum intended benefits in Kenya.

Evaluating effect modification by HIV testing history to understand the mechanisms behind the impact of announcing HIV self-testing availability in a clinic system in Kenya.

Background: In sub-Saharan Africa, truckers and female sex workers (FSWs) have high HIV risk and face challenges accessing HIV testing. Adding HIV self-testing (HIVST) to standard of care (SOC) programs increases testing rates. However, the underlying mechanisms are not fully understood. HIVST may decrease barriers (inconvenient clinic hours, confidentiality concerns) and thus we would expect a greater impact among those not accessing SOC testing (barriers prevented previous testing). As a new biomedical technology, HIVST may also be a cue to action (the novelty of a new product motivates people to try it), in which case we might expect the impact to be similar by testing history. Methods: We used data from two randomized controlled trials evaluating the announcement of HIVST availability via text-message to male truckers (n = 2,260) and FSWs (n = 2,196) in Kenya. Log binomial regression was used to estimate the risk ratio (RR) for testing ≤ 2 months post-announcement in the intervention vs. SOC overall and by having tested in the previous 12-months (12m-tested); and we assessed interaction between the intervention and 12m-tested. We also estimated risk differences (RD) per 100 and tested additive interaction using linear binomial regression. Results: We found no evidence that 12m-tested modified the HIVST impact. Among truckers, those in the intervention were 3.1 times more likely to test than the SOC (p < 0.001). Although testing was slightly higher among those not 12m-tested (RR = 3.5, p = 0.001 vs. RR = 2.7, p = 0.020), the interaction was not significant (p = 0.683). Among FSWs, results were similar (unstratified RR = 2.6, p < 0.001; 12m-tested: RR = 2.7, p < 0.001; not 12m-tested: RR = 2.5, p < 0.001; interaction p = 0.795). We also did not find significant interaction on the additive scale (truckers: unstratified RD = 2.8, p < 0.001; 12m-tested RD = 3.8, p = 0.037; not 12m-tested RD = 2.5, p = 0.003; interaction p = 0.496. FSWs: unstratified RD = 9.7, p < 0.001; 12m-tested RD = 10.7, p < 0.001, not 12m-tested RD = 9.1, p < 0.001; interaction p = 0.615). Conclusion: The impact of HIVST was not significantly modified by 12m-tested among truckers and FSWs on the multiplicative or additive scales. Announcing the availability of HIVST likely served primarily as a cue to action and testing clinics might maximize the HIVST benefits by holding periodic HIVST events to maintain the cue to action impact rather than making HIVST continually available.

The Impact on HIV Testing Over 6 Months When Free Oral HIV Self-Test Kits Were Available to Truck Drivers in Kenya: A Randomized Controlled Trial.

Background: Studies suggest that offering HIV self-testing (HIVST) increases short-term HIV testing rates, but few have looked at long-term outcomes. Methods: We conducted a randomized controlled trial (RIDIE 55847d64a454f) on the impact of offering free oral HIVST to 305 truck drivers recruited from two clinics in Kenya. We previously reported that those offered HIVST were more likely to accept testing. Here we report on the 6-month follow-up during which intervention participants could pick-up HIVST kits from eight clinics. Results: There was no difference in HIV testing during 6-month follow-up between participants in the intervention and the standard of care (SOC) arms (OR = 1.0, p = 0.877). The most common reasons given for not testing were lack of time (69.6%), low risk (27.2%), fear of knowing HIV status (20.8%), and had tested recently (8.0%). The null association was not modified by having tested at baseline (interaction p = 0.613), baseline risk behaviors (number of partners in past 6 months, interaction p = 0.881, had transactional sex in past 6 months, interaction p = 0.599), nor having spent at least half of the past 30 nights away from home for work (interaction p = 0.304). Most participants indicated a preference for the characteristics associated with the SOC [preference for blood-based tests (69.4%), provider-administered testing (74.6%) testing in a clinic (70.1%)]. However, those in the intervention arm were more likely to prefer an oral swab test than those in the SOC (36.6 vs. 24.6%, p = 0.029). Conclusions: Offering HIVST kits to truck drivers through a clinic network had little impact on testing rates over the 6-month follow-up when participants had to return to the clinic to access HIVST. Clinic-based distribution of HIVST kits may not address some major barriers to testing, such as lack of time to go to a clinic, fear of knowing one's status and low risk perception. Preferred HIV testing attributes were consistent with the SOC for most participants, but oral swab preference was higher among those in the intervention arm, who had seen the oral HIVST and had the opportunity to try it. This suggests that preferences may change with exposure to different testing modalities.

Applying a social-ecological lens to opinions about HIV self-testing among Kenyan truckers who declined to test: a qualitative study.

HIV prevalence among truckers in Africa is high and testing rates suboptimal. With numerous African countries having approved HIV self-testing kits, more information on how to design acceptable and accessible self-testing programs for high-risk populations is necessary. We explored views about self-testing via in-depth interviews with 24 truckers participating in a randomised controlled trial who refused HIV testing. A social-ecological lens was used to guide data analysis and frame study findings. While most participants said that they would use an HIV self-test, perceived barriers and facilitators were identified at multiple levels. Many participants noted lack of time to test or obtain a self-test kit as a major barrier (intrapersonal) and varied in their views about self-testing with a partner (interpersonal). Participants offered programmatic/policy recommendations, suggesting that they preferred accessing self-test kits in settings where training could be provided. Participants believed they should be able to pick up multiple test kits at the same time and that the test kits should be free or low cost. These study findings will help guide the design of self-testing programs for truckers and other mobile populations.

Depression and sexual risk behavior among long-distance truck drivers at roadside wellness clinics in Kenya.

BACKGROUND: Truck drivers in sub-Saharan Africa are at high risk for both mental health disorders and sexually transmitted infections. We sought to determine the prevalence of depression among a sample of long-distance truck drivers seeking services at roadside wellness clinics in Kenya and explore the relationship between depression and sexual risk behavior. METHODS: We used data from an interviewer-administered questionnaire from 284 truck drivers in Kenya who participated in a randomized controlled trial evaluating whether offering oral HIV self-testing could increase HIV test uptake. Depression was categorized based on the Patient Health Questionnaire-9 score, with a score ≥10 indicative of probable major depressive disorder (MDD). Sexual risk behavior was operationalized as the number of condomless sex partners in the past 6 months. RESULTS: The mean participant age was 36.9 years, 83.0% were married, and 37.0% had a secondary school education or higher. Overall, 24% of participants had probable MDD, and 58.2% reported having one condomless sex partner in the past 6 months, whereas 27.3% reported having had two or more. In a multivariable Poisson regression model adjusted for demographic and other relevant variables, including number of sex partners, MDD was significantly associated with a greater number of condomless sex partners (adjusted prevalence ratio 1.63, 95% confidence interval [1.25-2.12], p < 0.001). General self-efficacy significantly mediated the association between MDD and number of condomless sex partners. CONCLUSIONS: The high prevalence of depression highlights the need to test the feasibility and acceptability of mental healthcare interventions for this population, possibly integrated with HIV prevention services. Future research is needed to better understand the association between depression and sexual risk behavior, as well as the role of self-efficacy.

Announcing the availability of oral HIV self-test kits via text message to increase HIV testing among hard-to-reach truckers in Kenya: a randomized controlled trial.

BACKGROUND: Truckers in sub-Saharan Africa are at higher risk of contracting HIV than the general population. HIV self-testing may be a way to increase testing rates in this high-risk population. The objective of this randomized controlled trial was to assess whether informing truckers who do not test for HIV regularly about the availability of HIV self-testing kits at roadside wellness centers in Kenya using text messages would increase HIV testing rates compared to the current program in which they are sent text messages about the availability of HIV testing in general. METHODS: A sample of 2262 male truckers registered in the North Star Alliance electronic health record system who, based on these records, were not testing for HIV regularly were randomized to one of three study groups in which they were sent text messages about the availability of (1) oral HIV self-test kits at all 8 North Star Alliance Kenya clinics that was sent three times (intervention), (2) HIV testing in general (not self-testing) at all North Star Alliance clinics sent three times (enhanced standard of care [SOC]), or (3) HIV testing in general (not self-testing) at all North Star Alliance clinics sent one time (SOC). We looked at HIV testing over a 2-month study period following the first text. RESULTS: Truckers in the intervention group were significantly more likely to test for HIV compared to those in the enhanced SOC (OR = 2.7, p = 0.009). There was no difference in HIV testing between those in the enhanced SOC and the SOC groups. Of those in the intervention group who tested, 64.5% chose the self-test and 35.5% chose the standard provider-administered blood-based HIV test. Although the intervention more than doubled HIV testing rates, because HIV testing rates were so low in this population (by design as we selected irregular testers), even in the intervention group more than 96% of participants did not test. CONCLUSIONS: Announcing the availability of HIV self-testing via text message increased HIV testing rates among truckers who were not regularly accessing HIV testing. However, self-testing is only a partial solution to increasing testing rates in this hard to reach population. TRIAL REGISTRATION: This trial was registered prior to enrollment at the Registry for International Impact Evaluations (RIDIE STUDY ID: 582a2462ae2ab): http://ridie.3ieimpact.org/index.php?r=search/detailView&id=492 . It was also registered after completion at ClinicalTrials.gov ( ClinicalTrials.gov Identifier: NCT03662165): https://clinicaltrials.gov/ct2/show/NCT03662165?term=NCT03662165&type=Intr&cond=HIV&rank=1 .

A Randomized Controlled Trial to Increase HIV Testing Demand Among Female Sex Workers in Kenya Through Announcing the Availability of HIV Self-testing Via Text Message.

We assessed whether informing female sex workers about the availability of HIV self-testing at clinics in Kenya using text messages would increase HIV testing rates. We selected a sample of 2196 female sex workers registered in an electronic health record system who were irregular HIV testers and randomized them to be sent a text message announcing the availability of (1) HIV self-test kits sent three times (intervention), (2) general HIV testing sent three times (enhanced standard of care [SOC]), or (3) general HIV testing sent one time (traditional SOC). Participants in the intervention arm were significantly more likely to test for HIV during 2-month follow-up compared to those in the enhanced SOC (OR 1.9, p = 0.001). There was no difference in HIV testing between those in the enhanced SOC and the traditional SOC arms. Announcing the availability of HIV self-testing via text message increased HIV testing among this high-risk group.

Stated and revealed preferences for HIV testing: can oral self-testing help to increase uptake amongst truck drivers in Kenya?

BACKGROUND: Long-distance truck drivers in Africa are particularly at risk of HIV acquisition and offering self-testing could help increase testing coverage in this hard-to-reach population. The aims of this study are twofold: (1) to examine the preference structures of truck drivers in Kenya regarding HIV testing service delivery models and what they mean for the roll-out of HIV self-testing, and (2) to compare the preference data collected from a hypothetical discrete choice experiment with the actual choices made by participants in the intervention arm of a randomised controlled trial (RCT) who were offered HIV testing choices. METHODS: Using data from 150 truck drivers, this paper examines whether the stated preferences regarding HIV testing in a discrete choice experiment predict the actual test selected when offered HIV testing choices. Conditional logit models were used for main effects analysis and stratified models were run by HIV testing choices made in the trial to assess if the attributes preferred differed by test chosen. RESULTS: The strongest driver of stated preference among all participants was cost. However, two preferences diverged between those who actually chose self-testing in the RCT and those who chose a provider administered test: the type of test (p < 0.001) and the type of counselling (p = 0.003). Self-testers preferred oral-testing to finger-prick testing (OR 1.26 p = 0.005), while non-self-testers preferred finger-prick testing (OR 0.56 p < 0.001). Non-self-testers preferred in-person counselling to telephonic counselling (OR 0.64 p < 0.001), while self-testers were indifferent to type of counselling. Preferences in both groups regarding who administered the test were not significant. CONCLUSIONS: We found stated preference structures helped explain the actual choices participants made regarding the type of HIV testing they accepted. Offering oral testing may be an effective strategy for increasing willingness to test among certain groups of truck drivers. However, the importance of in-person counselling and support, and concern that an oral test cannot detect HIV infection may mean that continuing to offer finger-prick testing at roadside wellness centres will best align with the preferences of those already attending these facilities. More research is needed to explore whether who administers the HIV test (provider versus self) makes any difference. TRIAL REGISTRATION: This trial is registered with the Registry for International Development Impact Evaluations ( RIDE ID#55847d64a454f ).

Costing analysis of an SMS-based intervention to promote HIV self-testing amongst truckers and sex workers in Kenya.

OBJECTIVE: HIV testing rates in many sub-Saharan African countries have remained suboptimal, and there is an urgent need to explore strategic yet cost-effective approaches to increase the uptake of HIV testing, especially among high-risk populations. METHODS: A costing analysis was conducted for a randomized controlled trial (RCT) with male truckers and female sex workers (FSWs) registered in the electronic health record system (EHRS) of the North Star Alliance, which offers healthcare services at major transit hubs in Southern and East Africa. The RCT selected a sample of truckers and FSWs who were irregular HIV testers, according to the EHRS, and evaluated the effect of SMSs promoting the availability of HIV self-testing (HIVST) kits in Kenyan clinics (intervention program) versus a general SMS reminding clients to test for HIV (enhanced and standard program) on HIV testing rates. In this paper, we calculated costs from a provider perspective using a mixed-methods approach to identify, measure, and value the resources utilized within the intervention and standard programs. The results of the analysis reflect the cost per client tested. RESULTS: The cost of offering HIVST was calculated to be double that of routine facility-based testing (USD 10.13 versus USD 5.01 per client tested), primarily due to the high price of the self-test kit. In the two study arms that only offered provider-administered HIV testing in the clinic, only 1% of truckers and 6% of FSWs tested during the study period, while in the intervention arm, which also offered HST, approximately 4% of truckers and 11% of FSWs tested. These lower than expected outcomes resulted in relatively high cost per client estimates for all three study arms. Within the intervention arm, 65% of truckers and 72% of FSWs who tested chose the HIVST option. However, within the intervention arm, the cost per additional client tested was lower for FSWs than for truckers, at USD 0.15 per additional client tested versus USD 0.58 per additional client tested, driven primarily by the higher response rates. CONCLUSION: Whilst the availability of HIVST increased HIV testing among both truckers and FSWs, the cost of providing HIVST is higher than that of a routine health facility-based test, driven primarily by the price of the HIV self-test kit. Future research needs to identify strategies which increase demand for HIVST, and determine whether these strategies and the subsequent increased demand for HIVST are cost-effective in relation to the conventional facility based testing currently available.

Psychosocial characteristics of primary care-seeking long-distance truck drivers in Kenya and associations with HIV testing.

The 90-90-90 strategy from the Joint United Nations Programme on HIV/AIDS (UNAIDS) to end the AIDS epidemic by 2020 includes, as its first goal, to have 90% of all people living with HIV to know their status. Achieving this goal will depend on effectively reaching high risk populations, which include mobile populations such as truck drivers. This study aimed to characterise a sample of 305 truck drivers recruited from 2 roadside wellness clinics in Kenya in terms of anticipated HIV stigma, self-efficacy, fatalism, gender equity, sensation seeking, and self-esteem, and then determine the association of these psychosocial characteristics with HIV testing behaviour. Greater general self-efficacy was associated with higher income and more years working as a truck driver. Greater fatalism was associated with non-Christian religion, being married, and having a lower income. Greater gender equity was associated with completing high school, being married, and having higher income. Greater sensation seeking was associated with lower income and fewer years employed as a truck driver. In multivariable logistic regression adjusted for demographic variables, anticipated HIV stigma was negatively associated with having ever tested for HIV (adjusted odds ratio [aOR] = 0.79; 95% confidence interval [CI] = 0.63-0.98; p = 0.034) and self-esteem was positively associated with testing (aOR = 1.06; 95% CI = 1.00-1.12; p = 0.038). Associations with HIV testing behaviour were not significant for self-efficacy, fatalism, gender equity, or sensation seeking. Public health interventions aiming to reduce anticipated stigma and increase self-esteem may potentially increase the uptake of HIV testing among truck drivers. Further research is needed to better understand the influence of these psychosocial characteristics on HIV testing.

Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

Offering Self-administered Oral HIV Testing as a Choice to Truck Drivers in Kenya: Predictors of Uptake and Need for Guidance While Self-testing.

We assessed predictors of choosing self-administered oral HIV testing in the clinic with supervision versus the standard provider-administered blood test when offered the choice among 149 Kenyan truck drivers, described the types of guidance participants needed during self-testing and predictors of needing guidance. Overall, 56.38% of participants chose the self-test, 23.49% the provider-administered test, and 20.13% refused testing. In the adjusted regression models, each additional unit on the fatalism and self-efficacy scales was associated with 0.97 (p = 0.003) and 0.83 (p = 0.008) times lower odds of choosing the self-test, respectively. Overall, 52.38% of self-testers did so correctly without questions, 47.61% asked questions, and 13.10% required unsolicited correction from the provider. Each additional unit on the fatalism scale was associated with 1.07 times higher odds of asking for guidance when self-testing (p < 0.001). Self-administered oral HIV testing seems to be acceptable and feasible among Kenyan truck drivers, especially if given the opportunity to ask questions.

Antiretroviral treatment scale-up among persons living with HIV in Kenya: results from a nationally representative survey.

BACKGROUND: In 2007, 29% of HIV-infected Kenyans in need of antiretroviral therapy (ART), based on an immunologic criterion of CD4 ≤350 cells per microliter, were receiving ART. Since then, substantial treatment scale-up has occurred in the country. We analyzed data from the second Kenya AIDS Indicator Survey (KAIS 2012) to assess progress of treatment scale-up in Kenya. METHODS: KAIS 2012 was a nationally representative survey of persons aged 18 months to 64 years that collected information on HIV status, care, and treatment. ART eligibility was defined based on 2 standards: (1) 2011 Kenya eligibility criteria for ART initiation: CD4 ≤350 cells per microliter or co-infection with active tuberculosis and (2) 2013 World Health Organization (WHO) eligibility criteria for ART initiation: CD4 ≤500 cells per microliter, co-infection with active tuberculosis, currently pregnant or breastfeeding, and infected partners in serodiscordant relationships. Blood specimens were tested for HIV antibodies and HIV-positive specimens tested for CD4 cell counts. RESULTS: Among 13,720 adults and adolescents aged 15-64 years, 11,626 provided a blood sample, and 648 were HIV infected. Overall, 58.8% [95% confidence interval (CI): 52.0 to 65.5) were eligible for treatment using the 2011 Kenya eligibility criteria and 77.4% (95% CI: 72.4 to 82.4) using the 2013 WHO eligibility criteria. Coverage of ART was 60.5% (95% CI: 50.8 to 70.2) using the 2011 Kenya eligibility criteria and 45.9% (95% CI: 37.7 to 54.2) using the 2013 WHO eligibility criteria. CONCLUSIONS: ART coverage has increased from 29% in 2007 to 61% in 2012. If Kenya adopts the 2013 WHO guidelines for ART initiation, need for ART increases by an additional 19 percentage points and current coverage decreases by an additional 15 percentage points, representing an additional 214,000 persons who will need to be reached.

Applying a social-ecological lens to opinions about HIV self-testing among Kenyan truckers who declined to test: a qualitative study

HIV prevalence among truckers in Africa is high and testing rates suboptimal. With numerous African countries having approved HIV self-testing kits, more information on how to design acceptable and accessible self-testing programs for high-risk populations is necessary. We explored views about self-testing via in-depth interviews with 24 truckers participating in a randomised controlled trial who refused HIV testing. A social-ecological lens was used to guide data analysis and frame study findings. While most participants said that they would use an HIV self-test, perceived barriers and facilitators were identified at multiple levels. Many participants noted lack of time to test or obtain a self-test kit as a major barrier (intrapersonal) and varied in their views about self-testing with a partner (interpersonal). Participants offered programmatic/policy recommendations, suggesting that they preferred accessing self-test kits in settings where training could be provided. Participants believed they should be able to pick up multiple test kits at the same time and that the test kits should be free or low cost. These study findings will help guide the design of self-testing programs for truckers and other mobile populations

Male circumcision in Siaya and Bondo Districts, Kenya: prospective cohort study to assess behavioral disinhibition following circumcision.

BACKGROUND: Evidence for efficacy of male circumcision as an HIV prevention measure is increasing, but there is serious concern that men who are circumcised may subsequently adopt more risky sexual behaviors. METHODS: Using a prospective cohort study, we compared sexual behaviors of 324 recently circumcised and 324 uncircumcised men at 1, 3, 6, 9, and 12 months after circumcision/study enrollment. The main outcome indicators were incidence of sexual behaviors known to place men at increased risk of acquiring HIV, namely, having sex with partners other than their wife/wives for married men or other than "regular" girlfriends for unmarried men. RESULTS: During the first month following circumcision, men were 63% and 61% less likely to report having 0 to 0.5 and >0.5 risky sex acts/week, respectively, than men who remained uncircumcised. This difference disappeared during the remainder of follow-up, with no excess of reported risky sex acts among circumcised men. Similar results were observed for risky unprotected sex acts, number of risky sex partners, and condom use. DISCUSSION: During the first year post-circumcision, men did not engage in more risky sexual behaviors than uncircumcised men, suggesting that any protective effect of male circumcision on HIV acquisition is unlikely to be offset by an adverse behavioral impact.