Articles tagged as "Uganda"

Improving retention in HIV care

Barriers and facilitators to interventions improving retention in HIV care: a qualitative evidence meta-synthesis.

Hall BJ, Sou KL, Beanland R, Lacky M, Tso LS, Ma Q, Doherty M, Tucker JD. AIDS Behav. 2016 Aug 31. [Epub ahead of print]

Retention in HIV care is vital to the HIV care continuum. The current review aimed to synthesize qualitative research to identify facilitators and barriers to HIV retention in care interventions. A qualitative evidence meta-synthesis utilizing thematic analysis. Prospective review registration was made in PROSPERO and review procedures adhered to PRISMA guidelines. Nineteen databases were searched to identify qualitative research conducted with individuals living with HIV and their caregivers. Quality assessment was conducted using CASP and the certainty of the evidence was evaluated using CERQual. A total of 4419 citations were evaluated and 11 were included in the final meta-synthesis. Two studies were from high-income countries, 3 from middle-income countries, and 6 from low-income countries. A total of eight themes were identified as facilitators or barriers for retention in HIV care intervention: (1) stigma and discrimination, (2) fear of HIV status disclosure, (3) task shifting to lay health workers, (4) human resource and institutional challenges, (5) mobile health (mHealth), (6) family and friend support, (7) intensive case management, and, (8) relationships with caregivers. The current review suggests that task shifting interventions with lay health workers were feasible and acceptable. mHealth interventions and stigma reduction interventions appear to be promising interventions aimed at improving retention in HIV care. Future studies should focus on improving the evidence base for these interventions. Additional research is needed among women and adolescents who were under-represented in retention interventions.

Abstract access 

Editor’s notes: Retention in HIV care is defined as the continued engagement in health services from enrolment in care to discharge or death of an individual living with HIV. There is strong evidence for the clinical and public health benefits of early antiretroviral therapy initiation. Individuals retained in care have lower mortality and a higher likelihood of viral suppression. Universal test and treat strategies are dependent on successful retention in HIV care.

A qualitative evidence meta-synthesis utilising thematic analysis was conducted. Some 11 studies were ultimately included in the review. Task shifting to non-specialist community caregivers was the most common activity identified in the review. Other programmes included home-based care, case management, primary HIV medical care, counselling, and mHealth.

The findings of the meta-synthesis highlight eight themes that were identified as facilitators or barriers for retention in HIV care programmes. This offers important insights for improving retention in care. However, more research is necessary to understand the experience of important sub populations including pregnant women, children and adolescents and key populations including gay men and other men who have sex with men.  The authors also emphasise the need for studies to provide particular emphasis on the perspectives of individuals living with HIV and providers involved in programme delivery. This, they argue, would greatly enhance subsequent implementation and development of tailored programmes to retain individuals living with HIV in care.

Africa, Northern America
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Preventing intimate partner violence for HIV positive women

Relationship power and sexual violence among HIV-positive women in rural Uganda.

Conroy AA, Tsai AC, Clark GM, Boum Y, Hatcher AM, Kawuma A, Hunt PW, Martin JN, Bangsberg DR, Weiser SD. AIDS Behav. 2016 Sep;20(9):2045-53. doi: 10.1007/s10461-016-1385-y.

Gender-based power imbalances place women at significant risk for sexual violence, however, little research has examined this association among women living with HIV/AIDS. We performed a cross-sectional analysis of relationship power and sexual violence among HIV-positive women on antiretroviral therapy in rural Uganda. Relationship power was measured using the Sexual Relationship Power Scale (SRPS), a validated measure consisting of two subscales: relationship control (RC) and decision-making dominance. We used multivariable logistic regression to test for associations between the SRPS and two dependent variables: recent forced sex and transactional sex. Higher relationship power (full SRPS) was associated with reduced odds of forced sex (AOR = 0.24; 95 % CI 0.07-0.80; p = 0.020). The association between higher relationship power and transactional sex was strong and in the expected direction, but not statistically significant (AOR = 0.47; 95 % CI 0.18-1.22; p = 0.119). Higher RC was associated with reduced odds of both forced sex (AOR = 0.18; 95 % CI 0.06-0.59; p < 0.01) and transactional sex (AOR = 0.38; 95 % CI 0.15-0.99; p = 0.048). Violence prevention interventions with HIV-positive women should consider approaches that increase women's power in their relationships.

Abstract access 

Editor’s notes: This paper addresses the lack of research into relationship power and sexual violence among women living with HIV. The authors report on analysis of data, collected as part of an ongoing prospective cohort study on HIV medication adherence (Uganda AIDS Rural Treatment Outcomes (UARTO) study). The authors examined the association between relationship power and forced and transactional sex, based on their hypothesis that higher relationship power would be protective against both.

Participants for the main study were recruited from the Mbarara Regional Referral Hospital Immune Suppression Syndrome (ISS) Clinic, and in August 2007, the survey was modified for this sub-study to include measures on relationship power, intimate partner violence, stigma, social support, health behaviours, and food security. For the survey, relationship power was measured using the Sexual Relationship Power Scale (SRPS), which contains two subscales: relationship control (RC) and decision-making dominance (DMD).

The authors found a strong protective effect of relationship power on recent experience of forced sex and transactional sex among the participants. They also found that the association between RC and transactional sex was consistent with the association between RC and forced sex, which they suggest reveals that transactional sex, for these women, is associated with male dominance and control. That is, HIV-positive women with low relationship power may be more likely to engage in transactional sex due to poverty and food insecurity rather than for empowering reasons associated with agency.

The authors conclude with a call to consider the multiplicity of issues that need to be addressed for women living with HIV, including access to HIV care and treatment, social support, stigma and discrimination, disclosure, poverty and food security, and skills to negotiate safer sex and resolve conflict. In relationship to violence prevention they argue that anti-violence programmes should be integrated within HIV healthcare services as well as addressing structural factors through economic empowerment and gender transformative programmes.

Africa
Uganda
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Couples learning from couples: now is the time to test together

Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial.

Matovu JK, Todd J, Wanyenze RK, Kairania R, Serwadda D, Wabwire-Mangen F. BMC Infect Dis. 2016 Aug 8;16:379. doi: 10.1186/s12879-016-1720-y.

Background: Uptake of couples' HIV counseling and testing (couples' HCT) services remains largely low in most settings. We report the effect of a demand-creation intervention trial on couples' HCT uptake among married or cohabiting individuals who had never received couples' HCT.

Methods: This was a cluster-randomized intervention trial implemented in three study regions with differing HIV prevalence levels (range: 9-43 %) in Rakai district, southwestern Uganda, between February and September 2014. We randomly assigned six clusters (1:1) to receive the intervention or serve as the comparison arm using computer-generated random numbers. In the intervention clusters, individuals attended small group, couple and male-focused interactive sessions, reinforced with testimonies from 'expert couples', and received invitation coupons to test together with their partners at designated health facilities. In the comparison clusters, participants attended general adult health education sessions but received no invitation coupons. The primary outcome was couples' HCT uptake, measured 12 months post-baseline. Baseline data were collected between November 2013 and February 2014 while follow-up data were collected between March and April 2015. We conducted intention-to-treat analysis using a mixed effects Poisson regression model to assess for differences in couples' HCT uptake between the intervention and comparison clusters. Data analysis was conducted using STATA statistical software, version 14.1.

Results: Of 2135 married or cohabiting individuals interviewed at baseline, 42% (n = 846) had ever received couples' HCT. Of those who had never received couples' HCT (n = 1174), 697 were interviewed in the intervention clusters while 477 were interviewed in the comparison clusters. 73.6% (n = 513) of those interviewed in the intervention and 82.6% (n = 394) of those interviewed in the comparison cluster were interviewed at follow-up. Of those interviewed, 72.3% (n = 371) in the intervention and 65.2% (n = 257) in the comparison clusters received HCT. Couples' HCT uptake was higher in the intervention than in the comparison clusters (20.3% versus 13.7%; adjusted prevalence ratio (aPR) = 1.43, 95% CI: 1.02, 2.01, P = 0.04).

Conclusion: Our findings show that a small group, couple and male-focused, demand-creation intervention reinforced with testimonies from 'expert couples', improved uptake of couples' HCT in this rural setting.

Trial registration: ClinicalTrials.gov, NCT02492061. Date of registration: June 14, 2015.

Abstract  Full-text [free] access

Editor’s notes: Effective programmes to increase HIV testing uptake are necessary, given new guidance from WHO recommending an immediate offer of antiretroviral therapy (ART) to all people who test HIV-positive regardless of CD4 count. This HIV testing demand creation trial involving married or cohabiting couples residing in Rakai, Uganda sheds light on strategies for achieving 90% knowledge of HIV-positive serostatus among all people living with HIV. In reality, HIV-serodiscordant couples have a striking 50% HIV prevalence from their partnership. Knowledge of serostatus is therefore critical to preventing HIV transmission to the HIV-negative partner and to an offspring. Such knowledge is also the doorway to early initiation of ART with its proven clinical benefits for the HIV-positive partner and reduced risk of HIV transmission to the HIV-negative partner. This intervention trial contributes to the literature on couples’ testing uptake generated through studies in Rwanda and Zambia in which influential network agents invited couples to take up HIV testing and counselling together. This trial was conducted in a highly studied population that has undergone annual sero-surveillance for over 20 years. At baseline 94.6% of individuals interviewed had already had an HIV test, 42% had a history of previous couples’ HIV testing and counselling (HTC), and 62.3% had had tested for HIV in the past year. People who had never received couples’ HTC formed the study populations. Couples in the programme clusters participated in couple- and male-focused demand creation small groups in which ‘expert couples’ shared their couple testing experiences. It is not possible to know which components of this relatively expensive programme were most effective. Uptake of couples HTC was modest at 20.3% compared with 13.7% in the control arm. Since this trial was conducted, new promising technologies have come on the horizon, including self-testing and point of care testing. Combining these with concerted efforts to reduce stigma and discrimination while increasing access to ART should see steady increases in uptake of couples’ HCT. Further, there is enough evidence now to suggest that engaging men and encouraging couple-to-couple conversations about testing can influence couples’ decisions to have an HIV test.

Africa
Uganda
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Systematic review finds that the evidence for the impact of HCT on HIV acquisition is limited but scale-up remains vital to facilitate other proven interventions

The effect of HIV counselling and testing on HIV acquisition in sub-Saharan Africa: a systematic review.

Rosenberg NE, Hauser BM, Ryan J, Miller WC. Sex Transm Infect. 2016 Aug 16. pii: sextrans-2016-052651. doi: 10.1136/sextrans-2016-052651. [Epub ahead of print]

Objectives: Annually, millions of people in sub-Saharan Africa (SSA) receive HIV counselling and testing (HCT), a service designed to inform persons of their HIV status and, if HIV uninfected, reduce HIV acquisition risk. However, the impact of HCT on HIV acquisition has not been systematically evaluated. We conducted a systematic review to assess this relationship in SSA.

Methods: We searched for articles from SSA meeting the following criteria: an HIV-uninfected population, HCT as an exposure, longitudinal design and an HIV acquisition endpoint. Three sets of comparisons were assessed and divided into strata: sites receiving HCT versus sites not receiving HCT (Strata A), persons receiving HCT versus persons not receiving HCT (Strata B) and persons receiving couple HCT (cHCT) versus persons receiving individual HCT (Strata C).

Results: We reviewed 1635 abstracts; eight met all inclusion criteria. Strata A consisted of one cluster randomised trial with a non-significant trend towards HCT being harmful: incidence rate ratio (IRR): 1.4. Strata B consisted of five observational studies with non-significant unadjusted IRRs from 0.6 to 1.3. Strata C consisted of two studies. Both displayed trends towards cHCT being more protective than individual HCT (IRRs: 0.3-0.5). All studies had at least one design limitation.

Conclusions: In spite of intensive scale-up of HCT in SSA, few well-designed studies have assessed the prevention impacts of HCT. The limited body of evidence suggests that individual HCT does not have a consistent impact on HIV acquisition, and cHCT is more protective than individual HCT.

Abstract access  

Editor’s notes: Although it is plausible that knowing that you are HIV-negative might be an incentive for safer behaviour and thus reduce the risk of HIV acquisition, previous studies have not been conclusive.  HIV counselling and testing (HCT) is an integral part of other prevention and treatment activities (e.g. voluntary medical male circumcision (VMMC) or pre-exposure prophylaxis (PreP)). The findings from this systematic review suggest that with the available evidence individual HCT does not consistently have a protective or harmful effect on HIV acquisition. Couples’ HCT may be protective but the authors caution against a simplistic interpretation, reminding us of limited evidence including imprecise estimates and possibilities of bias. There were just two studies on couples’ HCT and convincing evidence of benefit was only seen in the study which compared couples’ HCT with individual HCT. There could be systematic differences between people who sought couples’ versus individual HCT (who may be unable or unwilling to take up a couples programme). While couples’ HCT may be suited to some people and be protective for them, the wider applicability may be more limited. The authors describe the methodological challenges of measuring the impact of an HCT activity on HIV acquisition, including the fact that large cohorts need to be effectively followed for long periods. In addition, randomised comparisons with no HCT are not possible because of ethical barriers to withholding HCT. Another challenge the authors cite is that both the primary exposure (HCT) and the primary outcome (HIV acquisition) require an HIV test. Arguably, this could be circumvented by offering anonymised remote (eg laboratory) HIV testing to determine HIV acquisition, rather than point-of-care tests where results would be immediately available. The final message from this paper is that although convincing evidence for reduction in HIV acquisition from HCT is not apparent, it’s scale-up must continue. HCT is the gateway to other proven activities for both prevention and treatment.

HIV testing
Africa
Rwanda, South Africa, Uganda, Zimbabwe
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Near elimination of HIV transmission with combined ART and PrEP

Integrated delivery of antiretroviral treatment and pre-exposure prophylaxis to HIV-1-serodiscordant couples: a prospective implementation study in Kenya and Uganda.

Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, Asiimwe S, Haberer JE, Morton J, Ngure K, Bulya N, Odoyo J, Tindimwebwa E, Hendrix C, Marzinke MA, Ware NC, Wyatt MA, Morrison S, Haugen H, Mujugira A, Donnell D, Celum C. PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016.

Background: Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

Methods and findings: Between November 5, 2012, and January 5, 2015, we enrolled and followed 1013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

Conclusions: Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Abstract  Full-text [free] access 

Editor’s notes: Long-term follow-up of the landmark HPTN-052 trial of ART for prevention of HIV transmission between HIV serodiscordant couples was covered in a recent issue of HIV This Month. In that trial, of the few transmission events that did occur, half were during the first few months of ART use in the HIV-positive partner, before viral load suppression. This study from Kenya and Uganda now suggests that offering pre-exposure prophylaxis (PrEP) to the HIV-negative partner to bridge the gap until virologic suppression may be an effective way to almost eliminate the risk of transmission.

In this study there were significant delays in ART initiation in the HIV-positive partner. At the start of the study the recommendation for ART initiation was a CD4+ cell count <350, and only half of the HIV-positive partners had initiated ART by six months. PrEP uptake by the HIV-negative partner was high during this time period and high levels of adherence were sustained, suggesting that this was a feasible and acceptable strategy for discordant couples.

The activities were delivered using specific clinical research facilities and staff, so the logical next step would be to demonstrate scalability with delivery through routine health systems and through more innovative community-based systems.  

Africa
Kenya, Uganda
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High spatial variation of HIV – implications for focused responses

Heterogeneity of the HIV epidemic in agrarian, trading, and fishing communities in Rakai, Uganda: an observational epidemiological study.

Chang LW, Grabowski MK, Ssekubugu R, Nalugoda F, Kigozi G, Nantume B, Lessler J, Moore SM, Quinn TC, Reynolds SJ, Gray RH, Serwadda D, Wawer MJ. Lancet HIV. 2016 Aug;3(8):e388-96. doi: 10.1016/S2352-3018(16)30034-0. Epub 2016 Jul 9.

Background: Understanding the extent to which HIV burden differs across communities and the drivers of local disparities is crucial for an effective and targeted HIV response. We assessed community-level variations in HIV prevalence, risk factors, and treatment and prevention service uptake in Rakai, Uganda.

Methods: The Rakai Community Cohort Study (RCCS) is an open, population-based cohort of people aged 15-49 years in 40 communities. Participants are HIV tested and interviewed to obtain sociodemographic, behavioural, and health information. RCCS data from Aug 10, 2011, to May 30, 2013, were used to classify communities as agrarian (n=27), trading (n=9), or lakeside fishing sites (n=4). We mapped HIV prevalence with Bayesian methods, and characterised variability across and within community classifications. We also assessed differences in HIV risk factors and uptake of antiretroviral therapy and male circumcision between community types.

Findings: 17 119 individuals were included, 9215 (54%) of whom were female. 9931 participants resided in agrarian, 3318 in trading, and 3870 in fishing communities. Median HIV prevalence was higher in fishing communities (42%, range 38-43) than in trading (17%, 11-21) and agrarian communities (14%, 9-26). Antiretroviral therapy use was significantly lower in both men and women in fishing communities than in trading (age-adjusted prevalence risk ratio in men 0.64, 95% CI 0.44-0.97; women 0.53, 0.42-0.66) and agrarian communities (men 0.55, 0.42-0.72; women 0.65, 0.54-0.79), as was circumcision coverage among men (vs trading 0.48, 0.42-0.55; vs agrarian 0.64, 0.56-0.72). Self-reported risk behaviours were significantly higher in men than in women and in fishing communities than in other community types.

Interpretation: Substantial heterogeneity in HIV prevalence, risk factors, and service uptake in Rakai, Uganda, emphasises the need for local surveillance and the design of targeted HIV responses. High HIV burden, risk behaviours, and low use of combination HIV prevention in fishing communities make these populations a priority for intervention.

Abstract access  

 

Editor’s notes: National estimates of HIV prevalence often conceal concentrated ‘sub-epidemics’ in particular geographical areas or populations. In this paper, the authors illustrate that within the Rakai region of Uganda, there is extensive community-level variation in HIV prevalence, behavioural risk factors, and HIV service coverage. Such clustering of HIV infections can reduce the impact of population-based prevention. UNAIDS, along with other organisations, have called for a more focused response to HIV treatment and prevention, concentrating efforts on key populations to increase the effectiveness of programmes. While regional and national data are important to provide an overview of the epidemic, they do not provide the in-depth picture that is necessary. Understanding the extent to which HIV prevalence differs across communities and the drivers of these differences is crucial to provide an effective, community-specific HIV response. In Rakai, HIV prevalence was 2-3 times higher, and ART use was nearly 50% lower, in fishing communities than in trading and agrarian communities.  However, the areas with the highest number of people living with HIV were in the larger, lower risk populations. One of the challenges of focused treatment and prevention programmes is the identification of geographical areas or sub-populations at highest risk. A better understanding of the community-level heterogeneity and transmission links between high and low risk areas is necessary. In this study, detailed household surveillance and epidemiological data were available; however, such fine-scale data are often not available. This finding of extensive heterogeneity across relatively close and seemingly similar communities has implications for focused approaches to HIV programmes, and demonstrates the importance of strong local HIV surveillance data.

Epidemiology
Africa
Uganda
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Updated evidence that DMPA increases HIV risk among women

Update on hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence, 2016.

Polis CB, Curtis KM, Hannaford PC, Phillips SJ, Chipato T, Kiarie JN, Westreich DJ, Steyn PS. AIDS. 2016 Aug 5. [Epub ahead of print]

Objective and design: Some studies suggest that specific hormonal contraceptive (HC) methods (particularly depot medroxyprogesterone acetate [DMPA]) may increase women's HIV acquisition risk. We updated a systematic review to incorporate recent epidemiological data.

Methods: We searched for articles published between 1/15/2014-1/15/2016, and hand-searched reference lists. We identified longitudinal studies comparing users of a specific HC method against either (1) non-users of HC, or (2) users of another specific HC method. We added newly identified studies to those in the previous review, assessed study quality, created forest plots to display results, and conducted a meta-analysis for data on DMPA versus no HC.

Results: We identified ten new reports: five were considered "unlikely to inform the primary question". We focus on the other five reports, along with 9 from the previous review, considered "informative but with important limitations". The preponderance of data for oral contraceptive pills, injectable norethisterone enanthate (NET-EN), and levonorgestrel implants do not suggest an association with HIV acquisition, though data for implants are limited. The new, higher-quality studies on DMPA (or non-disaggregated injectables), which had mixed results in terms of statistical significance, had hazard ratios (HR) between 1.2 and 1.7, consistent with our meta-analytic estimate for all higher-quality studies of HR 1.4.

Conclusions: While confounding in these observational data cannot be excluded, new information increases concerns about DMPA and HIV acquisition risk in women. If the association is causal, the magnitude of effect is likely ≤HR 1.5. Data for other hormonal contraceptive methods, including NET-EN, are largely reassuring.

Abstract access

Editor’s notes: For several years there has been debate about whether the risk of HIV acquisition in women may be increased by the use of hormonal contraception. A systematic review published in 2014 included a meta-analysis of data from 22 studies, and this paper adds 10 new studies to the analysis. While these new papers carried some of the previous review’s limitations which cannot be ignored, the new data also lends further strength to the evidence and renewed analysis. The authors found some encouraging results which suggest that there is no significant increased risk of HIV with the use of oral contraceptives and the NET-EN injectable. However, this analysis does suggest that there is an increased risk of 1.4-1.5 of HIV with the use of DMPA. This is particularly concerning given the widespread use of this product throughout the world, and especially in areas where high rates of new HIV infections continue to persist, such as sub-Saharan Africa. Studies continue to explore this association of risk, and will hopefully produce evidence in the near future to definitively provide guidance as to how clinicians should direct the use of DMPA in women at risk of HIV. 

Africa, Northern America
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Using HIV infrastructure to test for other diseases can reach many people at a low cost

Cost and efficiency of a hybrid mobile multi-disease testing approach with high HIV testing coverage in East Africa.

Chang W, Chamie G, Mwai D, Clark TD, Thirumurthy H, Charlebois ED, Petersen M, Kabami J, Ssemmondo E, Kadede K, Kwarisiima D, Sang N, Bukusi EA, Cohen CR, Kamya M, Havlir DV, Kahn JG. J Acquir Immune Defic Syndr. 2016 Jul 29. [Epub ahead of print]

Background: In 2013-14, we achieved 89% adult HIV testing coverage using a hybrid testing approach in 32 communities in Uganda and Kenya (SEARCH: NCT01864603). To inform scalability, we sought to determine: 1) overall cost and efficiency of this approach; and 2) costs associated with point-of-care (POC) CD4 testing, multi-disease services, and community mobilization.

Methods: We applied micro-costing methods to estimate costs of population-wide HIV testing in 12 SEARCH Trial communities. Main intervention components of the hybrid approach are census, multi-disease community health campaigns (CHC), and home-based testing (HBT) for CHC non-attendees. POC CD4 tests were provided for all HIV-infected participants. Data were extracted from expenditure records, activity registers, staff interviews, and time and motion logs.

Results: The mean cost per adult tested for HIV was $20.5 (range: $17.1 - $32.1) [2014 US$], including a POC CD4 test at $16 per HIV+ person identified. Cost per adult tested for HIV was $13.8 at CHC vs. $31.7 via HBT. The cost per HIV+ adult identified was $231 ($87 - $1245), with variability due mainly to HIV prevalence among persons tested (i.e., HIV positivity rate). The marginal costs of multi-disease testing at CHCs were $1.16/person for hypertension and diabetes, and $0.90 for malaria. Community mobilization constituted 15.3% of total costs.

Conclusions: The hybrid testing approach achieved very high HIV testing coverage, with POC CD4, at costs similar to previously reported mobile, home-based, or venue-based HIV testing approaches in sub-Saharan Africa. By leveraging HIV infrastructure, multi-disease services were offered at low marginal costs.

Abstract access 

Editor’s notes: Ensuring high rates of HIV testing is critical to managing the HIV epidemic in many countries. With a positive diagnosis, recent WHO recommendations suggest that people living with HIV can immediately be put onto treatment which improves their own health, alongside reducing the chance that they will pass on infection to others. There are many different ways to carry out HIV testing, and this study looks at the differences in costs between community health campaigns (which also test for other diseases including hypertension and diabetes), and home-based testing. This paper estimates that it was less costly to carry out a HIV test through a multi-disease community programme than home-based testing. The authors suggest that because of the robust infrastructure that has been developed for HIV testing in Uganda and Kenya, the additional cost for testing for other diseases is very low. There has been some criticism that the response to the HIV epidemic has been at the expense of reducing ill-health from other conditions. Using HIV infrastructure to support testing for diseases like hypertension and diabetes is a good way to counter these criticisms, and improve the overall health of the population. 

Africa
Kenya, Uganda
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Real-world barriers to active TB case detection in HIV clinics

Implementation and operational research: use of symptom screening and sputum microscopy testing for active tuberculosis case detection among HIV-infected patients in real-world clinical practice in Uganda.

Roy M, Muyindike W, Vijayan T, Kanyesigye M, Bwana M, Wenger M, Martin J, Geng E. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):e86-91. doi: 10.1097/QAI.0000000000001067.

Background: The uptake of intensified active TB case-finding among HIV-infected patients using symptom screening is not well understood. We evaluated the rate and completeness of each interim step in the TB pulmonary "diagnostic cascade" to understand real-world barriers to active TB case detection.

Methods: We conducted a cohort analysis of new, antiretroviral therapy-naive, HIV-infected patients who attended a large HIV clinic in Mbarara, Uganda (March 1, 2012-September 30, 2013). We used medical records to extract date of completion of each step in the diagnostic cascade: symptom screen, order, collection, processing, and result. Factors associated with lack of sputum order were evaluated using multivariate Poisson regression and chart review of 50 screen-positive patients.

Results: Of 2613 patients, 2439 (93%) were screened for TB and 682 (28%) screened positive. Only 90 (13.2%) had a sputum order. Of this group, 83% completed the diagnostic cascade, 13% were diagnosed with TB, and 50% had a sputum result within 1 day of their visit. Sputum ordering was associated with WHO stage 3 or 4 HIV disease and greater number of symptoms. The main identifiable reasons for lack of sputum order in chart review were treatment of presumed malaria (51%) or bacterial infection (43%).

Conclusions: The majority of newly enrolled HIV-infected patients who screened positive for suspected TB did not have a sputum order, and those who did were more likely to have more symptoms and advanced HIV disease. Further evaluation of provider behavior in the management of screen-positive patients could improve active TB case detection rates.

Abstract access  

Editor’s notes: This cohort analysis of people enrolling for HIV care at a President’s Emergency Plan for AIDS Relief (PEPFAR) clinic in Uganda used medical record review to identify barriers to active TB case finding in a programmatic setting. This study is unique in evaluating each step along the entire TB diagnostic cascade, from the WHO screening tool, which asks about four symptoms, through to sputum result, in a setting where TB diagnosis was based on sputum microscopy, prior to availability of Xpert ® MTB/RIF.

The authors found high uptake of TB symptom screening at enrolment to HIV care, with cough being the most commonly reported symptom. However, most people with symptoms suggestive of TB were not documented to have had sputum investigation ordered, this being the major point of loss from the TB diagnostic pathway. Given that the prevalence of active TB among people newly testing HIV positive is consistently high in African countries, this represents a substantial missed opportunity for prompt identification and treatment of TB. The study design did not allow in-depth evaluation of the reasons for lack of sputum order since this may not be clearly documented in medical records. Factors such as a person’s inability to produce sputum should also be considered. Ultimately, a high sensitivity, affordable, non-sputum based, point-of-care diagnostic test for TB is necessary to overcome the barriers inherent in the current complex TB diagnostic pathway.

Africa
Uganda
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Weekend breaks on efavirenz-based ART non-inferior in adolescents

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial.

Butler K, Inshaw J, Ford D, Bernays S, Scott K, Kenny J, Klein N, Turkova A, Harper L, Nastouli E, Paparini S, Choudhury R, Rhodes T, Babiker A, Gibb D. Health Technol Assess. 2016 Jun;20(49):1-108. doi: 10.3310/hta20490.

Background: For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives: To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy.

Design: Open, randomised, non-inferiority trial.

Setting: Europe, Thailand, Uganda, Argentina and the USA.

Participants: Young people (aged 8-24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of < 50 copies/ml for > 12 months.

Interventions: Young people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART).

Main outcome measures: Follow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan-Meier method (12% non-inferiority margin) adjusted for region and age.

Results: In total, 199 young people (11 countries) were randomised (n = 99 SCT group, n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm3, respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group, n = 5; CT group, n = 7). By 48 weeks, six participants in the SCT group and seven in the CT group had a confirmed VL > 50 copies/ml [difference -1.2%, 90% confidence interval (CI) -7.3% to 4.9%] and two in the SCT group and four in the CT group had a confirmed VL > 400 copies/ml (difference -2.1%, 90% CI -6.2% to 1.9%). All six participants in the SCT group with a VL > 50 copies/ml resumed daily ART, of whom five were resuppressed, three were on the same regimen and two with a switch; two others on SCT resumed daily ART for other reasons. Overall, three participants in the SCT group and nine in the CT group (p = 0.1) changed ART regimen, five because of toxicity, four for simplification reasons, two because of compliance issues and one because of VL failure. Seven young people (SCT group, n = 2; CT group, n = 5) had major non-nucleoside reverse transcriptase inhibitor mutations at VL failure, of whom two (n = 1 SCT group, n = 1 CT group) had the M184V mutation. Two young people had new Centers for Disease Control B events (SCT group, n = 1; CT group, n = 1). There were no significant differences between SCT and CT in grade 3/4 adverse events (13 vs. 14) or in serious adverse events (7 vs. 6); there were fewer ART-related adverse events in the SCT arm (2 vs. 14; p = 0.02). At week 48 there was no evidence that SCT led to increased inflammation using an extensive panel of markers. Young people expressed a strong preference for SCT in a qualitative substudy and in pre- and post-trial questionnaires. In total, 98% of the young people are taking part in a 2-year follow-up extension of the trial.

Conclusions: Non-inferiority of VL suppression in young people on EFV-based first-line ART with a VL of < 50 copies/ml was demonstrated for SCT compared with CT, with similar resistance, safety and inflammatory marker profiles. The SCT group had fewer ART-related adverse events. Further evaluation of the immunological and virological impact of SCT is ongoing. A limitation of the trial is that the results cannot be generalised to settings where VL monitoring is either not available or infrequent, nor to use of low-dose EFV. Two-year extended follow-up of the trial is ongoing to confirm the durability of the SCT strategy. Further trials of SCT in settings with infrequent VL monitoring and with other antiretroviral drugs such as tenofovir alafenamide, which has a long intracellular half-life, and/or dolutegravir, which has a higher barrier to resistance, are planned.

Trial registration: Current Controlled Trials ISRCTN97755073; EUDRACT 2009-012947-40; and CTA 27505/0005/001-0001.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (projects 08/53/25 and 11/136/108), the European Commission through EuroCoord (FP7/2007/2015), the Economic and Social Research Council, the PENTA Foundation, the Medical Research Council and INSERM SC10-US19, France, and will be published in full in Health Technology Assessment; Vol. 20, No. 49. See the NIHR Journals Library website for further project information.

Abstract  Full-text [free] access 

Editor’s notes: Adherence to ART has been shown to deteriorate in adolescence, with missed doses occurring particularly at weekends. Pharmacokinetic properties of some ART drugs, such as efavirenz, allow for a break in pill taking without a break in effective treatment. Non-inferiority trials evaluating five days on, two days off in adults have shown continuous ART to be non-inferior with low rates of virologic rebound.  This formed the rationale for this global, randomised Phase II/III trial in young people.

In the BREATHER trial, non-inferiority of viral suppression in adolescents on efavirenz-based first-line ART was shown for short-cycle treatment compared with continuous treatment. Overall 93% of adolescents remained virally suppressed. Findings from the two-year long-term follow-up phase will confirm if short-cycle treatment is effective and safe in this population.  Further studies are required to confirm the applicability of this strategy in real-life settings where viral load monitoring is likely to be less frequent than in a trial setting.

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