A community randomized controlled trial to investigate impact of improved STD management and behavioural interventions on HIV incidence in rural Masaka,Uganda: trial design,methods and baseline findings

OBJECTIVE: To describe study design, methods and baseline findings of a behavioural intervention alone and in combination with improved management of sexually transmitted diseases (STDs) aimed at reducing HIV incidence and other STDs. DESIGN: A three-arm community randomized controlled trial (RCT) of 18 rural communities (approximately 96 000 adults) in SW Uganda. A standardized behavioural intervention was implemented in 12 communities (arms A and B) through community-based education, meetings and information leaflets. Six of these communities in addition received improved STD management through government and private health units (arm B). Arm C communities received routine government health services. Impact assessment was through three questionnaire and serological surveys of 750-1000 adults in each community at 18-24-month intervals. The primary outcome measure was HIV incidence and secondary measures were syphilis and herpes simplex virus type 2 incidence, prevalence of Neisseria gonorrhoea and Chlamydia trachomatis and sexual behaviour changes. RESULTS: Approximately 15 000 adults (72% of eligible population) were enrolled at baseline. HIV baseline prevalence rates were 9-10% in all arms and demographic and behavioural characteristics and STD prevalence were also similar. In intervention communities, there were 391 995 attendance at 81 502 activities (6.1 per target adult), 164 063 leaflets distributed (2.6 per person) and 1 586 270 condoms (16.5 condoms per adult). In the STD communities a total of 12 239 STD cases (65% women) were seen over a 5-year period (7.7 per 100 adults/year). CONCLUSION: This is the first community RCT of its type with a behavioural component. There is fair baseline comparability between study arms and process data suggest that interventions were adequately implemented.     

Randomized controlled trial to investigate impact of site-based safer sex programmes in Kingston, Jamaica: trial design, methods and baseline findings

Objective To describe the design, methods and baseline findings of a multi‐level prevention intervention to increase consistent condom use among persons at public social sites in Kingston, Jamaica, who have new or concurrent sexual partnerships. Methods A two‐arm randomized controlled trial (RCT) of 147 sites where persons meet new sex partners. Sites were identified by community informants as places where people meet new sexual partners, which include bars, street locations, bus stops, malls and others. Sites were sorted into 50 clusters based on geographic proximity and type of site and randomized to receive a multi‐level site‐based intervention or not. Intervention components include on‐site HIV testing, condom promotion and peer education. Effectiveness of the intervention will be measured by comparing the proportion of persons with new or multiple partners in the past year who report recent inconsistent condom use at intervention vs. control sites. Results Baseline surveys were conducted at 66 intervention (711 men, 845 women) and 65 control sites (654 men, 738 women). Characteristics of intervention and control sites as well as the characteristics of patrons at these sites were similar. The outcome variable was balanced with approximately 30% of men and 25% of women at intervention and control sites reporting a new partner or more than one partner in the past year and recent inconsistent condom use. Conclusions The baseline findings confirm that the population is an appropriate target group for HIV prevention and that randomization will provide the means to estimate programme effectiveness.     

Effects of PREPARE,a Multi-component,School-Based HIV and Intimate Partner Violence (IPV) Prevention Programme on Adolescent Sexual Risk Behaviour and IPV: Cluster Randomised Controlled Trial

Young South Africans, especially women, are at high risk of HIV. We evaluated the effects of PREPARE, a multi-component, school-based HIV prevention intervention to delay sexual debut, increase condom use and decrease intimate partner violence (IPV) among young adolescents. We conducted a cluster RCT among Grade eights in 42 high schools. The intervention comprised education sessions, a school health service and a school sexual violence prevention programme. Participants completed questionnaires at baseline, 6 and 12 months. Regression was undertaken to provide ORs or coefficients adjusted for clustering. Of 6244 sampled adolescents, 55.3 % participated. At 12 months there were no differences between intervention and control arms in sexual risk behaviours. Participants in the intervention arm were less likely to report IPV victimisation (35.1 vs. 40.9 %; OR 0.77, 95 % CI 0.61–0.99; t(40) = 2.14) suggesting the intervention shaped intimate partnerships into safer ones, potentially lowering the risk for HIV.     

The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe--study design and baseline results

Objective To assess the effectiveness of a community‐based HIV prevention intervention for adolescents in terms of its impact on (1) HIV and Herpes simplex virus type 2 (HSV‐2) incidence and on rates of unintended pregnancy and (2) reported sexual behaviour, knowledge and attitudes. Methods Cluster randomised trial of a multi‐component HIV prevention intervention for adolescents based in rural Zimbabwe. Thirty communities were selected and randomised in 2003 to early or deferred intervention implementation. A baseline bio‐behavioural survey was conducted among 6791 secondary school pupils (86% of eligibles) prior to intervention implementation. Results Baseline prevalences were 0.8% (95% CI: 0.6–1.0) for HIV and 0.2% (95% CI: 0.1–0.3%) for HSV‐2. Four girls (0.12%) were pregnant. There was excellent balance between study arms. Orphans who made up 35% of the cohort were at increased risk of HIV [age–sex adjusted odds ratio 3.4 (95% CI: 1.7–6.5)]. 11.9% of young men and 2.9% of young women reported that they were sexually active (P < 0.001); however, there were inconsistencies in the sexual behaviour data. Girls were less likely to know about reproductive health issues than boys (P < 0.001) and were less likely to have used and to be able to access condoms (P < 0.001). Conclusion This is one of the first rigorous evaluations of a community‐based HIV prevention intervention for young people in southern Africa. The low rates of HIV suggest that the intervention was started before this population became sexually active. Inconsistency and under‐reporting of sexual behaviour re‐emphasise the importance of using externally validated measures of sexual risk reduction in behavioural intervention studies.     

Effect of a multicomponent behavioural PMTCT cluster randomised controlled trial on HIV stigma reduction among perinatal HIV positive women in Mpumalanga province,South Africa

Background: We evaluate the impact a multicomponent, behavioural, prevention of mother to child transmission (PMTCT), cluster randomised controlled trial on HIV stigma reduction among perinatal HIV infected women in rural South Africa. Methods: In a cluster randomised controlled trial, twelve community health centres (CHCs) in Mpumalanga Province, South Africa, were randomised; pregnant women living with HIV enrolled received either: A Standard Care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n =357), or an Enhanced Intervention (EI) condition of SC PMTCT plus the ‘Protect Your Family’ intervention (EI; 6 CHCs; n =342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions; those in the EI, four antenatal and two postnatal group PMTCT sessions, including stigma reduction, led by trained lay health workers. Maternal PMTCT, HIV knowledge and HIV related stigma were assessed. The impact of the EI was ascertained on stigma reduction (baseline, 12 months postnatally). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention. Results: In all, 699 women living with HIV were recruited during pregnancy (8–24 weeks), and assessments were completed prenatally at baseline and at 12 months (59.5%) postnatally. Baseline scores of overall HIV related stigma and the four scale factors (personalised stigma, disclosure concerns, negative self-image, and concern public attitudes) decreased at follow-up in the intervention group, while baseline scores of overall stigma and three scale factors (personalised stigma, negative self-image, and concern public attitudes) increased at follow-up in the control group. Using longitudinal analyses, Model 1, which included time-invariant predictors of stigma assessed over the two time periods of baseline and 12 months, increases in stigma from baseline to 12 months were associated with being unemployed, having been diagnosed with HIV before the current pregnancy, and alcohol use. In Model 2, which included time-varying predictors, lower stigma scores were associated with participation in the intervention, greater male partner involvement, and consistent condom use. Conclusion: The enhanced PMTCT intervention, including stigma reduction, administered by trained lay health workers had a significant effect on the reduction of HIV related stigma. Trial registration: clinicaltrials.gov: number NCT02085356     

HIV incidence during a cluster-randomized trial of two strategies providing voluntary counselling and testing at the workplace, Zimbabwe

OBJECTIVE: To investigate HIV incidence during a trial of two voluntary counselling and testing (VCT) strategies. Counselling may promote beneficial behavioural change, although knowledge of negative status does not appear to contribute further benefit. DESIGN: The parent cluster-randomized trial demonstrated much greater uptake of VCT when counselling and rapid testing were available on-site (intensive VCT) than through pre-paid vouchers to an external provider (standard VCT). Anonymous HIV tests had been requested from all employees at enrolment and after 2 years intervention. METHODS: The study setting was 22 businesses in Harare, Zimbabwe. Participants were 3146 HIV-negative individuals remaining in employment at the end of intervention, of whom 2966 (94.3%) consented to repeat testing. VCT linked to basic HIV care was provided and the main outcome measures were HIV incidence under each study arm, as a retrospective secondary analysis. RESULTS: Mean VCT uptake in this cohort was 70.7 and 5.2%, respectively, in the intensive and standard arms. Crude HIV incidence was 1.21 per 100 person-years, with non-significantly higher rates in the intensive VCT arm [mean site incidence 1.37 and 0.95 per 100 person-years, respectively; adjusted rate ratio 1.49 (95% confidence interval 0.79-2.80). CONCLUSIONS: Highly acceptable VCT did not reduce HIV incidence in this predominantly male cohort. HIV incidence was highest in the high uptake VCT arm, lending support to a US trial in which rapid testing appeared to have adverse behavioural consequences in some HIV-negative clients. Careful comparison of outcomes under different counselling and testing strategies is needed to maximize HIV prevention from global scale-up of VCT.     

Syndromic treatment of sexually transmitted diseases reduces the proportion of incident HIV infections attributable to these diseases in rural Tanzania

OBJECTIVES: To compare the proportion of HIV seroconversions attributable to other sexually transmitted diseases in the intervention and comparison arms of the Mwanza sexually transmitted diseases (STD) intervention trial. DESIGN: Case-control study of 96 cases of HIV seroconversion and 974 HIV-negative controls, nested within the Mwanza trial cohort. METHODS: Data on reported STD symptoms during 2 years of follow-up, and serological evidence of recent syphilis, were used to obtain odds ratios (ORs) for HIV seroconversion, adjusted for community, age, marital status, sex partners and travel. Population-attributable fractions (PAF) of HIV seroconversions associated with these STD exposures were calculated separately for the intervention and comparison arms, and for men and women. RESULTS: In men in the comparison arm, adjusted ORs for ulcers (14.8), discharge (3.3), any symptom (4.1) and any STD (4.0) were highly significant. There were no significant associations between HIV incidence and STD exposures in the intervention arm. The PAF were consistently higher in the comparison arm than the intervention arm. In men, the PAF for any STD was 39.6% [95% confidence interval (CI), 12.4-58.3)] in the comparison arm but only 12.0% (CI, 0.0-35.9) in the intervention arm. The PAF for women were lower than for men. CONCLUSIONS: These are minimal PAF estimates and they do not account for STD effects on HIV infectiousness. Nevertheless, a substantial proportion of new HIV infections in men in the comparison arm were attributable to STD. Lower PAF in the intervention arm than in the comparison arm for men provide further evidence of the role of STD cofactors in HIV transmission, supporting the hypothesis that the Mwanza intervention reduced the duration of symptomatic STD, thus reducing the HIV risk associated with such STD.     

Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town,South Africa

Female adolescents from socioeconomically underserved communities in Cape Town, South Africa, who have dropped out of school, use substances, and engage in risky sex behaviour are at risk of HIV. Tailored gender-focused HIV behavioural interventions for this key population are needed to mitigate these risk factors. A pilot trial of a woman-focused risk-reduction intervention for adolescents was conducted (N?=?100), with a one-month follow-up appointment. Participants in the intervention group attended two group workshops. Data were examined for significant differences within and between the groups. At baseline, 94% of participants tested positive for cannabis, 17% were HIV-positive and 11% were pregnant. Ninety-two participants returned for 1-month follow-up. At follow-up, the proportion who tested positive for cannabis use decreased significantly in both the intervention (p?=?0.07) and control groups (p?=?0.04). Impaired sex with any partner (p?=?0.02), or with main partner (p?=?0.06) decreased among the intervention group. Impaired sex with a main partner was less likely in the intervention group (p?=?0.07) in the regression model. In conclusion, findings indicate a need for HIV prevention interventions among out-of-school female adolescents. Intervention acceptability was high, and there were some decreases in sexual risk behaviour among intervention participants which is promising. Future intervention research with this key population involving larger sample sizes and longer follow-up periods will help to determine intervention efficacy.     

Implementation and impact of a technology-based HIV risk-reduction intervention among Thai men who have sex with men using “Vialogues”: a randomized controlled trial

ABSTRACT

We conducted a randomized control trial to evaluate the impact of a novel technology-based intervention on HIV risks and condom use behaviors among Thai men who have sex with men (MSM). Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months were randomly assigned to control and intervention arm, and received HIV testing at baseline, month 6 and 12. Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com. Of 76 MSM enrolled, 37 were randomized to intervention and 39 to control arm. Median age was 28 (IQR 24–32) years. Thirty-three (89.2%) intervention arm participants completed all 12-monthly Vialogues sessions. At month 12, intervention arm had higher retention rate (p?=?0.029) and higher median percentage of condom use for anal intercourse (p?=?0.023) versus control arm. Over the 12-month period, intervention arm reported significant reduction in self-perceived HIV risk (p?=?0.001), popper usage (p?=?0.002), median number of sexual partners (p?=?0.003), and increased median condom use percentage (p?=?0.006). Our study highlights that “Vialogues” intervention significantly reduced number of sexual partners and condomless anal intercourse rates among Thai MSM, and has positive implications for reducing epidemic among key populations.     

The challenge of promoting safe sex at sites where persons meet new sex partners in Jamaica: results of the Kingston PLACE randomized controlled trial

Objective To determine whether a site‐based Priorities for Local AIDS Control Efforts (PLACE) HIV prevention intervention in Kingston, Jamaica increased condom use among persons with new or multiple sex partners. Methods A total of 147 sites where persons go to meet new sex partners were grouped into 50 geographic clusters and randomized to receive or not receive a multilevel PLACE prevention intervention. Baseline cross‐sectional surveys of sites and patrons at sites were conducted in 2005 to determine the nature of social activities at sites to better plan the intervention and to ensure that the two arms of the trial were similar. The intervention was delivered by 50 trained outreach workers between January and June 2006. After the intervention two cross‐sectional surveys were conducted to assess the extent of intervention implementation and to estimate the proportion of patrons at sites with recent new or concurrent partnerships and inconsistent condom use. Results Characteristics of sites and patrons were similar for most variables at intervention and control sites at both baseline and post‐intervention. A total of 1535 patrons (723 men, 812 women) were interviewed at intervention sites and 1324 patrons (661 men, 663 women) at control sites 6–9 months after the intervention. There were no significant differences between intervention and control groups in the proportions of men (37.8% and 31.6%) and women (24.6% and 22.6%) who reported new or multiple relationships in the past year and inconsistent condom use. There was no significant difference in the proportion of men or women showing a condom at interview, having a HIV test in the past 12 months or being exposed to the intervention. Conclusions An intent‐to‐treat analysis did not show any intervention effect. This was probably because of difficulty in implementing the intervention, the extent of patron mixing among sites, the intensity of national education campaigns, delay in conducting the post‐intervention survey and evidence of other interventions at some control sites.     

The impact of attending a behavioural intervention on HIV incidence in Masaka, Uganda

OBJECTIVE: Changing behaviour is an important method for preventing HIV infection. We examined why a community randomized trial of a behavioural intervention found no significant effect of this on HIV incidence in rural Uganda. DESIGN: An individual-level analysis of a community randomized trial. METHODS: All sexually active, initially HIV-seronegative individuals with data on sexual behaviour were included (1558 men and 1836 women). Uptake of the intervention was measured using self-reported attendance at meetings, videos, dramas, and interactions with community educators in the past year. Sexual behaviour was assessed using self-reported condom use and the number of sexual partners in the past year. RESULTS: Overall, 81% of individuals in the intervention communities and 9% in the comparison communities reported attending at least one of the intervention activities in the past year. Attendance was lower in women, in those aged 55 years or older, and in the widowed. There was a lower HIV incidence in those who reported attending at least one intervention activity compared with those who attended none, and in women this effect was statistically significant (in women, adjusted rate ratio 0.41, 95% CI 0.19-0.89, P = 0.024; in men, adjusted rate ratio 0.66, 95% CI 0.25-1.79, P = 0.42). Reported behaviour change did not differ markedly between those who did and did not report attending any intervention activities. CONCLUSION: Although the intervention had no significant benefit in the communities as a whole, it resulted in a reduced risk of HIV acquisition in women who attended it. The methodological implications for future trials are discussed.     

Impact of a Single Session of Counseling on Partner Referral for Sexually Transmitted Disease Treatment, Harare, Zimbabwe

Counseling patients with sexually transmitted diseases (STD) to refer their partners to treatment is considered a means of preventing reinfection and controlling the spread of STD and is standard practice throughout the world. We conducted a randomized controlled trial to assess the impact of an enhanced counseling session on partner referral in Harare, Zimbabwe. The intervention consisted of an individualized confidential session with a trained counselor; standard care (control) relied on the treating clinician to discuss partner referral. A consecutive sample of 272 patients (135 men, 137 women) was randomly assigned to the intervention or control group; 137 (50%) completed follow- up. By intent-to-treat analysis, persons in the intervention arm were more likely to report notifying any partner compared to controls (92% vs. 67%, adjusted odds ratio 4.1, 95% confidence interval 1.3–13.2, p < .001). Across both study arms, women and married persons were more likely to notify partners, particularly spouses. Few persons notified casual partners. Qualitative data at follow-up identified diverse motivating factors and barriers to partner referral. A short, low-cost counseling session may increase the number of spouses referred to STD treatment in resource-poor, high-morbidity areas of sub-Saharan Africa. New methods of treating or notifying casual partners need to be evaluated.     

Using motivational interviewing to promote adherence to antiretroviral medications: a randomized controlled study

The primary aim of this study was to test an intervention to support antiretroviral medication adherence among primarily low-income men and women with HIV. The study was a randomized controlled trial (Get Busy Living) with participants assigned to treatment (Motivational Interviewing [MI]) and control groups. Participants were recruited from an HIV/AIDS clinic in Atlanta, Georgia, US. Of those referred to the study, 247 completed a baseline assessment and were enrolled with 125 randomized to the intervention group and 122 to the control group. Participants were patients beginning antiretroviral therapy or changing to a new drug regimen. The intervention consisted of five MI sessions delivered by registered nurses in individual counselling sessions. Participants were paid for each session attended. The intervention sought to build confidence, reduce ambivalence and increase motivation for ART medication-taking. Medication adherence was measured by the Medication Event Monitoring System (MEMS) from the time of screening until the final follow-up conducted approximately 12 months following the baseline assessment. Participants in the intervention condition showed a trend towards having a higher mean percent of prescribed doses taken and a greater percent of doses taken on schedule when compared to the control group during the months following the intervention period. This effect was noted beginning at about the eighth month of the study period and was maintained until the final study month. Although the finding was weaker for overall percent of prescribed doses taken, the results for the percent of doses taken on schedule suggests that the MI intervention may be a useful approach for addressing specific aspects of medication adherence, such as adherrence to a specified dosing schedule.     

Outcomes and lessons from a pilot RCT of a community-based HIV prevention multi-session group intervention for gay men

This paper presents the first outcome evaluation of multi-session groupwork for HIV prevention among gay men in the UK. This community-based RCT recruited 50 men, of whom 42% were HIV-positive or untested, and 32% reported status unknown or serodiscordant UAI in the previous 12 months. No knowledge, skills, attitudinal or behavioural differences were detected between intervention and control at baseline. At eight weeks, those attending the group reported significant gains over their control in making sexual choices, physical safety, HIV and STI transmission knowledge, and sexual negotiation skills. At 20 weeks, significant differences remained for HIV and STI transmission knowledge and comfort with sexual choices. Although no behavioural differences were detected, the aims of the National Prevention Strategy were met. This pilot RCT is appraised in the light of modest sample size and attrition, and recommendations for establishing behavioural outcomes are presented. This study has demonstrated that high-risk community samples can be recruited to multi-session interventions, and has provided feasibility data for future rigorous evaluation designs.     

Reducing the risk of HIV infection during pregnancy among South African women: A randomized controlled trial

Mpumalanga Province, South Africa has one of the highest HIV/AIDS diagnosis rates among pregnant women (~29.4%). This study sought to enhance male involvement in pregnancy to increase HIV disclosure, sexual communication, HIV knowledge and reduce unprotected sex. Participants attending Antenatal Clinics (ANC) completed HIV counseling and testing and were enrolled with male partners (n=239 couples, 478 individuals). Twelve ANCs were randomly assigned to provide a prevention of mother-to-child transmission (PMTCT) intervention or the standard of care, health education sessions plus PMTCT. Participants were assessed at baseline and post-intervention (approximately 6–8 weeks post-baseline) on demographics, sexual behavior, HIV-related knowledge, and conflict resolution strategies. Experimental participants increased HIV knowledge, use of negotiation, and decreased intimate partner violence. Additionally, they were more likely to have increased condom use from baseline to post-intervention (OR=5.1, 95% CI=[2.0, 13.3]). Seroconversions in the control condition exceeded experimental (6 vs. 0). HIV serostatus disclosure to partner did not increase over time for men or women within the experimental or control condition. Male involvement in pregnancy may be an important strategy to reduce sexual risk behavior and HIV transmission. Results support the utility of group interventions to enhance communication and HIV knowledge among pregnant couples.     

Decline in sexually transmitted infection prevalence and HIV incidence in female barworkers attending prevention and care services in Mbeya Region, Tanzania

OBJECTIVE: To assess trends in sexually transmitted infection (STI) prevalence and HIV incidence and associated factors in a cohort of female barworkers exposed to behavioural interventions and STI screening and treatment. METHODS: An open cohort of 600 female barworkers in Mbeya Region, Tanzania was offered 3-monthly information and education sessions on HIV/STI and reproductive health, voluntary HIV counselling and testing and clinical health check-ups including STI syndromic management with simple STI laboratory support. Outcome assessments included HIV, herpes simplex virus type 2 (HSV-2) and syphilis serology, polymerase chain reaction for Neisseria gonorrhoeae, Chlamydia trachomatis and ulcerative STI, microscopy for Trichomonas vaginalis, Candida albicans and bacterial vaginosis and interviews on sociodemographic and behavioural characteristics. RESULTS: Over a period of 30 months 600 barworkers were enrolled at the baseline examination round and 153 thereafter as replacements for losses to follow-up. At 3-monthly examinations the prevalence of gonorrhoea declined steadily from 22.2 to 6.8% (odds ratio for trend per quarter: 0.81; P < 0.001). The prevalence of all other STI/RTI, except for genital herpes and bacterial vaginosis, also decreased significantly. HIV incidence declined from 13.9/100 to 5.0/100 person-years over three consecutive 9-month periods. HIV incidence was significantly associated with genital ulcers and positive syphilis serology, but not with genital herpes or HSV-2 seropositivity. CONCLUSION: A relatively simple intervention consisting of regular 3-monthly STI screening and syndromic management in combination with HIV/STI information and counselling sessions was well accepted and effective in reducing STI among barworkers. Such interventions should be implemented more widely in high-risk environments in sub-Saharan Africa.     

Evaluation of a Peer Network-Based Sexual Risk Reduction Intervention for Men in Beer Halls in Zimbabwe: Results from a Randomized Controlled Trial

While much emphasis has been placed on involving men in AIDS prevention in sub-Saharan Africa, there remain few rigorously evaluated interventions in this area. A particularly appealing point of intervention is the sexual risk behavior associated with men’s alcohol consumption. This article reports the outcomes of The Sahwira HIV Prevention Program, a male-focused, peer-based intervention promoting the idea that men can assist their friends in avoiding high-risk sexual encounters associated with alcohol drinking. The intervention was evaluated in a randomized, controlled trial (RCT) implemented in 24 beer halls in Harare, Zimbabwe. A cadre of 413 male beer hall patrons (~20% of the patronage) was trained to assist their male peers within their friendship networks. Activities included one-on-one interactions, small group discussions, and educational events centering on the theme of men helping their male friends avoid risk. Venues were randomized into 12 control versus 12 intervention beer halls with little cross-contamination between study arms. The penetration and impact of the intervention were assessed by pre- and post-intervention cross-sectional surveys of the beer hall patronage. The intervention was implemented with a high degree of fidelity to the protocol, with exposure to the intervention activities significantly higher among intervention patrons compared to control. While we found generally declining levels of risk behavior in both study arms from baseline to post-intervention, we found no evidence of an impact of the intervention on our primary outcome measure: episodes of unprotected sex with non-wife partners in the preceding 6 months (median 5.4 episodes for men at intervention beer halls vs. 5.1 among controls, P = 0.98). There was also no evidence that the intervention reduced other risks for HIV. It remains an imperative to find ways to productively engage men in AIDS prevention, especially in those venues where male bonding, alcohol consumption, and sexual risk behavior are intertwined.     

Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya

Aims Dual epidemics of human immunodeficiency virus (HIV) and alcohol use disorders, and a dearth of professional resources for behavioral treatment in sub‐Saharan Africa, suggest the need for development of culturally relevant and feasible interventions. The purpose of this study was to test the preliminary efficacy of a culturally adapted six‐session gender‐stratified group cognitive–behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among HIV‐infected out‐patients in Eldoret, Kenya. Design Randomized clinical trial comparing CBT against a usual care assessment‐only control. Setting A large HIV out‐patient clinic in Eldoret, Kenya, part of the Academic Model for Providing Access to Healthcare collaboration. Participants Seventy‐five HIV‐infected out‐patients who were antiretroviral (ARV)‐initiated or ARV‐eligible and who reported hazardous or binge drinking. Measurements Percentage of drinking days (PDD) and mean drinks per drinking days (DDD) measured continuously using the Time line Follow back method. Findings There were 299 ineligible and 102 eligible out‐patients with 12 refusals. Effect sizes of the change in alcohol use since baseline between the two conditions at the 30‐day follow‐up were large [d = 0.95, P = 0.0002, mean difference = 24.93, 95% confidence interval (CI): 12.43, 37.43 PDD; d = 0.76, P = 0.002, mean difference = 2.88, 95% CI: 1.05, 4.70 DDD]. Randomized participants attended 93% of the six CBT sessions offered. Reported alcohol abstinence at the 90‐day follow‐up was 69% (CBT) and 38% (usual care). Paraprofessional counselors achieved independent ratings of adherence and competence equivalent to college‐educated therapists in the United States. Treatment effect sizes were comparable to alcohol intervention studies conducted in the United States. Conclusions Cognitive–behavioral therapy can be adapted successfully to group paraprofessional delivery in Kenya and may be effective in reducing alcohol use among HIV‐infected Kenyan out‐patients.     

The Impact of a Community-based Pilot Health Education Intervention for Older People as Caregivers of Orphaned and Sick Children as a Result of HIV and AIDS in South Africa

The increasing HIV and AIDS epidemic in South Africa poses a substantial burden to older people, in particular older women who mainly provide care for sick adult children and their grandchildren who have become orphaned and rendered vulnerable by the death or illness of their parents. In this study, 202 isiXhosa speaking older caregivers from Motherwell in the Eastern Cape Province of South Africa were trained to provide care for grandchildren and adult children living with HIV or AIDS. Based on a community needs assessment, a health education intervention comprising four modules was designed to improve skills and knowledge which would be used to assist older people in their care-giving tasks. Some topics were HIV and AIDS knowledge, effective intergenerational communication, providing home-based basic nursing care, accessing social services and grants, and relaxation techniques. Structured one-on-one interviews measured differences between pre-intervention and post-intervention scores among those who attended all four modules vs. those that missed one or more of the sessions. The results demonstrated that older people who participated in all four workshops perceived themselves more able and in control to provide nursing care. The participants also showed a more positive attitude towards people living with HIV or AIDS and reported an increased level of HIV and AIDS knowledge. The results provided valuable information upon which the development of future interventions may be based and psychosocial and structural needs of the older caregivers may be addressed by relevant stakeholders.