Impact of Community Support Workers in Rural Ethiopia on Emotional and Psychosocial Health of Persons Living with HIV: Results of a Three-Year Randomized Community Trial.

People living with HIV face multiple psychosocial challenges. In a large, predominantly rural Ethiopian region, 1799 HIV patients new to care were enrolled from 32 sites in a cluster randomized trial using trained community support workers with HIV to provide individual health education, counseling and social support. Participants received annual surveys through 36 months using items drawn from the Centre for Epidemiologic Studies Depression Scale-10, Medical Outcome Study Social Support Survey, and HIV/AIDS Stigma Instrument-PLWA. At 12 months (using linear mixed effects regression models controlling for enrollment site clustering), intervention participants had greater emotional/informational and tangible assistance social support scores, and lower scores assessing depression symptoms and negative self-perception due to HIV status. A significant treatment effect at 36 months was also seen on scores assessing emotional/informational social support, depression symptoms, and internalized stigma. An intervention using peer community support workers with HIV to provide individualized informational and psychological support had a positive impact on the emotional health of people living with HIV who were new to care.(ClinicalTrials.gov protocol ID: 1410S54203, May 19, 2015).

A three-year randomized community trial of community support workers in rural Ethiopia to promote retention in HIV care.

Retention in care is a major challenge for global AIDS control, including sub-Saharan Africa. In a large Ethiopian region, we evaluated an intervention where HIV positive community support workers (CSWs) provided HIV health education, personal counseling and social support for HIV patients new to care. We enrolled 1,799 patients recently entering care from 32 hospitals and health centers, randomized to intervention or control sites. Dates of all clinic visits, plus deaths or transfers were abstracted from HIV medical records. Primary outcomes were gap in clinical care (>90 days from a missed clinical or drug pickup appointment) and death. For 36 months of follow-up, and for the first 12 months after enrollment, weighted risk differences [RD] between treatment arms were modest and non-significant for gap in clinical care, death or either outcome. Through 36 months, 624 of 980 controls and 469 of 819 intervention participants had gaps in clinical care (RD = -5.5%, 95% confidence interval [CI] = -17.9%, 7.0%); 79 controls and 82 intervention participants died (RD = 2.5% 95% CI = -1.7%, 6.8%). Factors including HIV stigma and a volatile political climate may have attenuated the advantages we anticipated, demonstrating how benefits of CSW interventions may depend upon psychosocial, clinical and structural factors particular to specific community settings.

Disclosure of HIV status among patients new to HIV care in Southern Ethiopia: role of perceived social support and other factors.

Reports from Sub-Saharan Africa, with a large HIV-infected population, vary widely in how often HIV status is disclosed to others, including spouses and other partners. We surveyed 1799 Ethiopian HIV patients newly enrolled in care within the previous 3 months at one of 32 local hospitals and health centers about disclosure of HIV status and two perceived social support domains: emotional/informational (EI) and tangible assistance (TA) support. Disclosure to another person was reported by 1389 (77%) persons. Disclosure rates to specific persons were: spouses or other partners = 74%; mothers = 24%; fathers = 16%; children = 26%; other family members = 37%; friends = 19%, and neighbors/other community members = 13%. Disclosure to another person was associated with higher social support scores on both EI and TA domains, marriage, and a longer time knowing HIV status. In multivariate adjusted models, disclosure to any person, as well as disclosure specifically to a spouse or partner, were associated with higher EI and higher TA social support scores. Provision of knowledgeable and emotionally supportive assistance can be an important factor in facilitating HIV disclosure. Helping persons with HIV decide who to disclose to and how to do so in the most positive manner is an essential component of HIV care and support.

Perceived social support among HIV patients newly enrolled in care in rural Ethiopia.

Social support significantly enhances physical and mental health for persons with human immunodeficiency virus (HIV). We surveyed 142 rural Ethiopian HIV patients newly enrolled in care for perceived social support and factors associated with low support levels. Using the Social Provisions Scale (SPS), the mean summary score was 19.1 (possible scores = 0-48). On six SPS subscales, mean scores (possible scores = 0-8), were: Reliable Alliance (others can be counted on for tangible assistance) = 2.8, Attachment (emotional closeness providing sense of security) = 2.9, Reassurance of Worth (recognition of competence and value by others) = 3.2, Guidance (provision of advice or information by others) = 3.2, Social Integration (belonging to a group with similar interests and concerns) = 3.5, and Nurturance (belief that others rely on one for their well-being) = 3.6. In multivariate analysis, factors significantly associated with lower social support scores were: lower education level (did not complete primary school) (p = .019), lower total score on knowledge items about HIV care/treatment (p = .038), and greater number of external stigma experiences in past three months (p < .001); greater number of chronic disease symptoms was of borderline significance (p = .098). Among rural Ethiopian patients newly entering HIV care, we found moderate and varying levels of perceived social support, with lowest scores for subscales reflecting emotional closeness and reliance on others for tangible assistance. Given that patients who have recently learned their diagnosis and entered care may be an especially vulnerable group, programs to help identify and address social support needs can provide multiple benefits in facilitating the best possible physical, emotional and functional quality of life for people living with HIV.

Factors associated with adherence amongst 5295 people receiving antiretroviral therapy as part of an international trial.

BACKGROUND: We assessed factors associated with antiretroviral therapy (ART) adherence, including specific ART medications. METHODS: The Strategies for Management of Antiretroviral Therapy study was an international antiretroviral therapy (ART) strategy trial that compared intermittent ART, using CD4(+) T-cell count as a guide, to continuous ART. Adherence during the 7 days before each visit was measured using self-report. We defined high adherence as self-report of taking "all" pills for each prescribed ART medication; all other reports were defined as suboptimal adherence. Factors associated with adherence were assessed using logistic regression with generalized estimating equations. RESULTS: Participants reported suboptimal adherence at 6016 of 35 695 study visits (17%). Factors independently associated with suboptimal adherence were black race, protease inhibitor-containing regimens, greater pill burden, higher maximum number of doses per day, and smoking. Factors independently associated with higher adherence were older age, higher education, region of residence, episodic treatment, higher latest (at the time of adherence) CD4(+) T-cell count, and being prescribed concomitant drugs (ie, medications for comorbidities). Of specific drugs investigated, atazanavir, atazanavir/ritonavir, fosamprenavir, indinavir, indinavir/ritonavir, and lopinavir/ritonavir were associated with suboptimal adherence, and tenofovir disoproxil fumarate/emtricitabine was associated with higher adherence. CONCLUSIONS: In this, the largest analysis of ART adherence to date, some protease inhibitor-containing regimens and regimens with >1 dose per day were associated with suboptimal adherence.

Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.

BACKGROUND: For people with HIV and CD4+ counts >500 cells/mm3, early initiation of antiretroviral therapy (ART) reduces serious AIDS and serious non-AIDS (SNA) risk compared with deferral of treatment until CD4+ counts are <350 cells/mm3. Whether excess risk of AIDS and SNA persists once ART is initiated for those who defer treatment is uncertain. METHODS: The Strategic Timing of AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults with CD4+ counts .500 cells/mm3 to immediate treatment initiation after random assignment (n = 2325) or deferred treatment (n= 2359). In 2015, a 57% lower risk of the primary end point (AIDS, SNA, or death) for the immediate group was reported, and the deferred group was offered ART. This article reports the follow-up that continued to December 31, 2021. Cox proportional-hazards models were used to compare hazard ratios for the primary end point from randomization through December 31, 2015, versus January 1, 2016, through December 31, 2021. RESULTS: Through December 31, 2015, approximately 7 months after the cutoff date from the previous report, the median CD4+ count was 648 and 460 cells/mm3 in the immediate and deferred groups, respectively, at treatment initiation. The percentage of follow-up time spent taking ART was 95% and 36% for the immediate and deferred groups, respectively, and the time-averaged CD4+ difference was 199 cells/mm3. After January 1, 2016, the percentage of follow-up time on treatment was 97.2% and 94.1% for the immediate and deferred groups, respectively, and the CD4+ count difference was 155 cells/mm3. After January 1, 2016, a total of 89 immediate and 113 deferred group participants experienced a primary end point (hazard ratio of 0.79 [95% confidence interval, 0.60 to 1.04] versus hazard ratio of 0.47 [95% confidence interval, 0.34 to 0.65; P<0.001]) before 2016 (P=0.02 for hazard ratio difference). CONCLUSIONS: Among adults with CD4+ counts >500 cells/mm3, excess risk of AIDS and SNA associated with delaying treatment initiation was diminished after ART initiation, but persistent excess risk remained. (Funded by the National Institute of Allergy and Infectious Diseases and others.).

Gonorrhoea or chlamydia in a U.S. military HIV-positive cohort.

OBJECTIVES: To investigate the epidemiology and risk factors of gonorrhoea (GC) or chlamydia (CT) coinfection in an HIV-positive US military cohort, focusing on the time after participants' knowledge of HIV diagnosis. METHODS: The authors analysed data from 4461 participants enrolled in the U.S. Military Natural History Study cohort for GC or CT infection ≥6 months after their HIV-positive test. RESULTS: During a mean follow-up of 7.08 years, 482 (11%) participants acquired a GC or CT infection. Of these, 283 (6%) acquired a GC infection, 278 (6%) acquired a CT infection and 123 (3%) had multiple GC or CT infections during follow-up. Risk of GC or CT infection was significantly greater in those younger, male, African-American and with a history of GC or CT infection. CONCLUSIONS: Frequent GC and CT diagnoses observed among members of this HIV-positive cohort indicate substantial ongoing risk behaviours that raise concerns for HIV transmission and underscore the need for continued screening to help identify and treat these sexually transmitted infections in this population.

Results of a 25-year longitudinal analysis of the serologic incidence of syphilis in a cohort of HIV-infected patients with unrestricted access to care.

BACKGROUND: The well-described biologic and epidemiologic associations of syphilis and HIV are particularly relevant to the military, as service members are young and at risk for sexually transmitted infections. We therefore used the results of serial serologic testing to determine the prevalence, incidence, and risk factors for incident syphilis in a cohort of HIV-infected Department of Defense beneficiaries. METHODS: Participants with a positive nontreponemal test at HIV diagnosis that was confirmed on treponemal testing were categorized as prevalent cases, and participants with an initial negative nontreponemal test who subsequently developed a confirmed positive nontreponemal test were categorized as incident cases. RESULTS: At HIV diagnosis, the prevalence of syphilis was 5.8% (n = 202). A total of 4239 participants contributed 27,192 person-years (PY) to the incidence analysis and 347 (8%) developed syphilis (rate, 1.3/100 PY; [1.1, 1.4]). Syphilis incidence was highest during the calendar years 2006 to 2009 (2.5/100 PY; [2.0, 2.9]). In multivariate analyses, younger age (per 10 year increase hazard ratio [HR], 0.8; [0.8-0.9]), male gender (HR, 5.6; [2.3-13.7]), non-European-American ethnicity (African-American HR, 3.2; [2.5-4.2]; Hispanic HR, 1.9; [1.2-3.0]), and history of hepatitis B (HR, 1.5; [1.2-1.9]) or gonorrhea (HR, 1.4; [1.1-1.8]) were associated with syphilis. CONCLUSIONS: The significant burden of disease both at and after HIV diagnosis, observed in this cohort, suggests that the cost-effectiveness of extending syphilis screening to at-risk military members should be assessed. In addition, HIV-infected persons continue to acquire syphilis, emphasizing the continued importance of prevention for positive programs.

Smoking and HIV: prevalence, health risks, and cessation strategies.

Health hazards due to smoking may undermine benefits of HIV treatment on morbidity and mortality. Over 40% of persons with HIV are current smokers. Health risks of smoking include increases in some HIV-associated infections, cardiovascular disease, some cancers, bacterial pneumonia and other lung disease, and overall mortality. Proven strategies for smoking cessation include various counseling approaches, nicotine replacement therapy and other pharmacotherapy; approaches may need to be individualized to address specific client needs and comorbidities. HIV clinicians and other service providers can have an influential role in screening their patients for smoking and promoting cessation programs to improve health.

Clinical, demographic and laboratory parameters at HAART initiation associated with decreased post-HAART survival in a U.S. military prospective HIV cohort.

BACKGROUND: Although highly active antiretroviral therapy (HAART) has improved HIV survival, some patients receiving therapy are still dying. This analysis was conducted to identify factors associated with increased risk of post-HAART mortality. METHODS: We evaluated baseline (prior to HAART initiation) clinical, demographic and laboratory factors (including CD4+ count and HIV RNA level) for associations with subsequent mortality in 1,600 patients who began HAART in a prospective observational cohort of HIV-infected U.S. military personnel. RESULTS: Cumulative mortality was 5%, 10% and 18% at 4, 8 and 12 years post-HAART. Mortality was highest (6.23 deaths/100 person-years [PY]) in those with ≤ 50 CD4+ cells/mm3 before HAART initiation, and became progressively lower as CD4+ counts increased (0.70/100 PY with ≥ 500 CD4+ cells/mm3). In multivariate analysis, factors significantly (p < 0.05) associated with post-HAART mortality included: increasing age among those ≥ 40 years (Hazard ratio [HR] = 1.32 per 5 year increase), clinical AIDS events before HAART (HR = 1.93), ≤ 50 CD4+ cells/mm3 (vs. CD4+ ≥ 500, HR = 2.97), greater HIV RNA level (HR = 1.36 per one log10 increase), hepatitis C antibody or chronic hepatitis B (HR = 1.96), and HIV diagnosis before 1996 (HR = 2.44). Baseline CD4+ = 51-200 cells (HR = 1.74, p = 0.06), and hemoglobin < 12 gm/dL for women or < 13.5 for men (HR = 1.36, p = 0.07) were borderline significant. CONCLUSIONS: Although treatment has improved HIV survival, defining those at greatest risk for death after HAART initiation, including demographic, clinical and laboratory correlates of poorer prognoses, can help identify a subset of patients for whom more intensive monitoring, counseling, and care interventions may improve clinical outcomes and post-HAART survival.

HIV/AIDS stigma-associated attitudes in a rural Ethiopian community: characteristics, correlation with HIV knowledge and other factors, and implications for community intervention.

BACKGROUND: Whether scale-up of HIV prevention and care will reduce negative attitudes and discriminatory practices towards persons living with HIV/AIDS (PLWH) is uncertain. An HIV knowledge and attitude survey was conducted in a rural Ethiopian community where HIV prevention and treatment was being rapidly scaled up. Data were analyzed to identify prevalence of and factors associated with stigma-associated attitudes towards PLWH. METHODS: We surveyed 561 adults from 250 randomly selected households in the rural town of Arba Minch and surrounding villages about positive or negative attitudes towards PLWH, as well as demographic characteristics, and knowledge about HIV transmission and treatment. RESULTS: Eighty percent of respondents agreed with ≥ 1 negative statements indicating blame or shame towards PLWH and 41% agreed with ≥ 1 negative statements associated with distancing themselves from PLWH. However, only 14% expressed negative responses about whether PLWH should receive support from their communities. In multivariate analysis, a greater number of negative attitudes towards PLWH was significantly (p < 0.05) associated with: female gender (Odds Ratio [OR] = 1.51), living in a rural village (vs. town neighborhood) (OR = 3.44), not knowing PLWH can appear healthy (OR = 1.78), lack of knowledge about perinatal transmission (OR = 1.49), lack of knowledge about how HIV is not transmitted (e.g. casual contact) (OR = 2.05), lack of knowledge about HIV treatment (OR = 1.80), and not personally knowing a PLWH (OR = 1.41). CONCLUSIONS: In a rural Ethiopian setting in which rapid scale-up of HIV treatment occurred, many respondents still characterized HIV as associated with shame or blame, or indicated PLWH would be isolated or discriminated against. HIV stigma can hamper both prevention and treatment programs. We identified multiple issues which, if addressed, can help promote a more positive cycle in which PLWH are appreciated as members of one's own community who are affirmatively interacted with and supported. Stigma reduction programs should address knowledge gaps such as fears of casual contact contagion, and lack of awareness of medical interventions to help prevent HIV disease, as well as building upon community-based attitudes of the importance of supporting and showing compassion for PLWH.

Long-term CD4+ lymphocyte response following HAART initiation in a U.S. Military prospective cohort.

BACKGROUND: Among HIV-infected persons initiating highly active antiretroviral therapy (HAART), early CD4+ lymphocyte count increases are well described. However, whether CD4+ levels continue to increase or plateau after 4-6 years is controversial. METHODS: To address this question and identify other determinants of CD4+ response, we analyzed data for 1,846 persons from a prospective HIV military cohort study who initiated HAART, who had post-HAART CD4+ measurements, and for whom HIV seroconversion (SC) date was estimated. RESULTS: CD4+ count at HAART initiation was ≤ 200 cells/mm3 for 23%, 201-349 for 31%, 350-499 for 27%, and ≥500 for 19%. The first 6 months post-HAART, the greatest CD4+ increases (93-151 cells) occurred, with lesser increases (22-36 cells/year) through the first four years. Although CD4+ changes for the entire cohort were relatively flat thereafter, HIV viral load (VL) suppressors showed continued increases of 12-16 cells/year. In multivariate analysis adjusting for baseline CD4+ and post-HAART time interval, CD4+ responses were poorer in those with: longer time from HIV SC to HAART start, lower pre-HAART CD4+ nadir, higher pre-HAART VL, and clinical AIDS before HAART (P < 0.05). CONCLUSIONS: Small but positive long-term increases in CD4+ count in virally suppressed patients were observed. CD4+ response to HAART is influenced by multiple factors including duration of preceding HIV infection, and optimized if treatment is started with virally suppressive therapy as early as possible.

Epidemiology of Hepatitis B virus infection in a US cohort of HIV-infected individuals during the past 20 years.

BACKGROUND: The epidemiologic trends of hepatitis B virus (HBV) infection in human immunodeficiency virus (HIV)-infected patients over the past 20 years are largely unknown. METHODS: Prevalence and risk factors for HBV infection overall, at the time of HIV infection, and after HIV infection were examined in an ongoing observational HIV cohort study. Risk factors for HBV infection at the time of diagnosis of HIV infection were evaluated using logistic regression, and risk of incident HBV infection after diagnosis of HIV infection was evaluated using Cox proportional hazards models. RESULTS: Of the 2769 evaluable participants, 1078 (39%) had HBV infection, of whom 117 (11%) had chronic HBV infection. The yearly cross-sectional prevalence of HBV infection decreased from a peak of 49% in 1995 to 36% in 2008 (P < .001). The prevalence of HBV infection at the time of diagnosis of HIV infection decreased during 1989-2008 from 34% to 9% (P < .001). The incidence of HBV infection after diagnosis of HIV infection decreased from 4.0 cases per 100 person-years during the pre-highly active antiretroviral therapy (HAART) era to 1.1 cases per 100 person-years during the HAART era (P < .001); however, this incidence remained unchanged during 2000-2008 (P = .49), with >20% of HBV infections occurring after HIV infection being chronic. Decreased risk of HBV infection after diagnosis of HIV infection was associated with higher CD4 cell count and the use of HBV-active HAART. Receipt of 1 dose of HBV vaccine was not associated with reduced risk of HBV infection after diagnosis of HIV infection. CONCLUSIONS: Although the burden of HBV infection overall is slowly decreasing among HIV-infected individuals, the persistent rate of HBV infection after diagnosis of HIV infection raises concern that more-effective prevention strategies may be needed to significantly reduce the prevalence of HBV infection in this patient population.

Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials.

PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). RESULTS: Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.

Smoking-related health risks among persons with HIV in the Strategies for Management of Antiretroviral Therapy clinical trial.

OBJECTIVES: We sought to determine smoking-related hazard ratios (HRs) and population-attributable risk percentage (PAR%) for serious clinical events and death among HIV-positive persons, whose smoking prevalence is higher than in the general population. METHODS: For 5472 HIV-infected persons enrolled from 33 countries in the Strategies for Management of Antiretroviral Therapy clinical trial, we evaluated the relationship between baseline smoking status and development of AIDS-related or serious non-AIDS events and overall mortality. RESULTS: Among all participants, 40.5% were current smokers and 24.8% were former smokers. Adjusted HRs were higher for current than for never smokers for overall mortality (2.4; P < .001), major cardiovascular disease (2.0; P = .002), non-AIDS cancer (1.8; P = .008), and bacterial pneumonia (2.3; P < .001). Adjusted HRs also were significantly higher for these outcomes among current than among former smokers. The PAR% for current versus former and never smokers combined was 24.3% for overall mortality, 25.3% for major cardiovascular disease, 30.6% for non-AIDS cancer, and 25.4% for bacterial pneumonia. CONCLUSIONS: Smoking contributes to substantial morbidity and mortality in this HIV-infected population. Providers should routinely integrate smoking cessation programs into HIV health care.

Determination of the underlying cause of death in three multicenter international HIV clinical trials.

PURPOSE: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. METHOD: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated. RESULTS: Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10% AIDS-defining diseases, 21% non-AIDS malignancies, 9% cardiac diseases, 9% liver disease, 8% non-AIDS-defining infections, 5% suicides, 5% other traumatic events/accidents, 4% drug overdoses/acute intoxications, 11% other causes, and 18% unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. CONCLUSION: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

BACKGROUND: Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. OBJECTIVES: We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. METHODS: Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. RESULTS: 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm3, and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. CONCLUSIONS: This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

Implementation of a Peer HIV Community Support Worker Program in Rural Ethiopia to Promote Retention in Care.

Retention in care is a major challenge for HIV treatment programs, including in rural and in resource-limited settings. To help reduce loss to follow-up (LTFU) for HIV-infected patients new to care in rural Ethiopia, 142 patients were assigned 1 of 13 trained community health support workers (CHSWs) who were HIV positive and from the same neighborhood/village. The CHSWs provided HIV and health education, counseling/social support, and facilitated communication with the HIV clinics. With 7 deaths and 3 transfers, the 12-month retention rate was 94% (95% CI = 89%-97%), and no client was LTFU in the project. Between enrollment and 12 months, clients had significant ( P ≤ .001) improvements in HIV knowledge (17% increase), physical and mental quality of life (81% and 21% increase), internalized stigma (97% decrease), and perceived social support (24% increase). In rural and resource-limited settings, community-based CHSW programs can complement facility-based care in reducing LTFU and improving positive outcomes for HIV-infected people who enter care.

Improved quality of life with immediate versus deferred initiation of antiretroviral therapy in early asymptomatic HIV infection.

OBJECTIVE: To determine if immediate compared to deferred initiation of antiretroviral therapy (ART) in healthy persons living with HIV had a more favorable impact on health-related quality of life (QOL), or self-assessed physical, mental, and overall health status. DESIGN: QOL was measured in the Strategic Timing of Antiretroviral Therapy study, which randomized healthy ART-naive persons living with HIV with CD4 cell counts above 500 cells/µl from 35 countries to immediate versus deferred ART. METHODS: At baseline, months 4 and 12, then annually, participants completed a visual analog scale (VAS) for 'perceived current health' and the Short-Form 12-Item Health Survey version 2 from which the following were computed: general health perception; physical component summary (PCS); and mental component summary (MCS); the VAS and general health were rated from 0 (lowest) to 100 (highest). RESULTS: QOL at study entry was high (mean scores: VAS = 80.9, general health = 72.5, PCS = 53.7, MCS = 48.2). Over a mean follow-up of 3 years, changes in all QOL measures favored the immediate group (P < 0.001); estimated differences were as follows: VAS = 1.9, general health = 3.6, PCS = 0.8, MCS = 0.9. When QOL changes were assessed across various demographic and clinical subgroups, treatment differences continued to favor the immediate group. QOL was poorer in those experiencing primary outcomes; however, when excluding those with primary events, results remained favorable for immediate ART recipients. CONCLUSION: In an international randomized trial in ART-naive participants with above 500 CD4 cells/µl, there were modest but significant improvements in self-assessed QOL among those initiating ART immediately compared to deferring treatment, supporting patient-perceived health benefits of initiating ART as soon as possible after an HIV diagnosis.