A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial

ObjectiveTo determine the effectiveness of a brief cognitive behavioural intervention in reducing the incidence of sexually transmitted infections among gay men.DesignRandomised controlled trial with 12 months'' follow up.SettingSexual health clinic in London.Participants343 gay men with an acute sexually transmitted infection or who reported having had unprotected anal intercourse in the past year.Results72% (361/499) of men invited to enter the study did so. 90% (308/343) of participants returned at least one follow up questionnaire or re-attended the clinic and requested a check up for sexually transmitted infections during follow up. At baseline, 37% (63/172) of the intervention group and 30% (50/166) of the control group reported having had unprotected anal intercourse in the past month. At 12 months, the proportions were 27% (31/114) and 32% ( 39/124) respectively (P=0.56). However, 31% (38/123) of the intervention group and 21% (35/168) of controls had had at least one new infection diagnosed at the clinic (adjusted odds ratio 1.66, 95% confidence interval 1.00 to 2.74). Considering only men who requested a check up for sexually transmitted infections, the proportion diagnosed with a new infection was 58% (53/91) for men in the intervention group and 43% (35/81) for men in the control group (adjusted odds ratio 1.84, 0.99 to 3.40). Using a regional database that includes information from 23 sexual health clinics in London, we determined that few participants had attended other sexual health clinics.ConclusionsThis behavioural intervention was acceptable and feasible to deliver, but it did not reduce the risk of acquiring a new sexually transmitted infection among these gay men at high risk. Even carefully designed interventions should not be assumed to bring benefit. It is important to evaluate their effects in randomised trials with objective clinical end points.

What is already known on this topic

The need for effective HIV prevention strategies based on reducing sexual risk behaviour remains importantFew interventions to reduce sexual risk behaviour have been rigorously evaluated using randomised controlled trials

What this study adds

This is the first randomised controlled trial of an intervention addressing sexual behaviour in homosexual men that uses sexually transmitted infections and self reported behaviour as end pointsThe intervention was brief and feasible to use in a busy clinic, but it did not reduce the risk of participants acquiring new infectionsThe potential for behavioural interventions to do more harm than good needs to be taken seriously     

The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England

Background

Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up.

Methods and Findings

Twenty-seven representative schools in England, with over 9,000 pupils aged 13–14 y at baseline, took part in the trial. Schools were randomised to either peer-led sex education (intervention) or to continue their usual teacher-led sex education (control). Peer educators, aged 16–17 y, were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools. The sessions used participatory learning methods designed to improve the younger pupils'' skills in sexual communication and condom use and their knowledge about pregnancy, sexually transmitted infections (STIs), contraception, and local sexual health services. Main outcome measures were abortion and live births by age 20 y, determined by anonymised linkage of girls to routine (statutory) data. Assessment of these outcomes was blind to sex education allocation. The proportion of girls who had one or more abortions before age 20 y was the same in each arm (intervention, 5.0% [95% confidence interval (CI) 4.0%–6.3%]; control, 5.0% [95% CI 4.0%–6.4%]). The odds ratio (OR) adjusted for randomisation strata was 1.07 (95% CI 0.80–1.42, p = 0.64, intervention versus control). The proportion of girls with one or more live births by 20.5 y was 7.5% (95% CI 5.9%–9.6%) in the intervention arm and 10.6% (95% CI 6.8%–16.1%) in the control arm, adjusted OR 0.77 (0.51–1.15). Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y (7.2% intervention versus 11.2% control, adjusted OR 0.62 [95% CI 0.42–0.91], weighted for non-response; response rate 61% intervention, 45% control). There were no significant differences for girls or boys in self-reported unprotected first sex, regretted or pressured sex, quality of current sexual relationship, diagnosed sexually transmitted diseases, or ability to identify local sexual health services.

Conclusion

Compared with conventional school sex education at age 13–14 y, this form of peer-led sex education was not associated with change in teenage abortions, but may have led to fewer teenage births and was popular with pupils. It merits consideration within broader teenage pregnancy prevention strategies.

Trial registration:

ISRCTN (ISRCTN94255362).     

Effects of remote,retroactive intercessory prayer on outcomes in patients with bloodstream infection: randomised controlled trial

ObjectiveTo determine whether remote, retroactive intercessory prayer, said for a group of patients with a bloodstream infection, has an effect on outcomes.Design Double blind, parallel group, randomised controlled trial of a retroactive intervention.Setting University hospital.Subjects All 3393 adult patients whose bloodstream infection was detected at the hospital in 1990-6.InterventionIn July 2000 patients were randomised to a control group and an intervention group. A remote, retroactive intercessory prayer was said for the well being and full recovery of the intervention group.Results Mortality was 28.1% (475/1691) in the intervention group and 30.2% (514/1702) in the control group (P for difference=0.4). Length of stay in hospital and duration of fever were significantly shorter in the intervention group than in the control group (P=0.01 and P=0.04, respectively).Conclusions Remote, retroactive intercessory prayer said for a group is associated with a shorter stay in hospital and shorter duration of fever in patients with a bloodstream infection and should be considered for use in clinical practice.

What is already known on this topic

Two randomised controlled trials of remote intercessory prayer (praying for persons unknown) showed a beneficial effect in patients in an intensive coronary care unitA recent systematic review found that 57% of the randomised, placebo controlled trials of distant healing showed a positive treatment effect

What this study adds

Remote intercessory prayer said for a group of patients is associated with a shorter hospital stay and shorter duration of fever in patients with a bloodstream infection, even when the intervention is performed 4-10 years after the infection     

Sexual behaviour of adolescents in Nigeria: cross sectional survey of secondary school students

ObjectivesTo determine whether family structure (polygamous or monogamous) is associated with sexual activity among school students in Nigeria.DesignCross sectional school survey with a two stage, clustered sampling design.Participants4218 students aged 12-21 years attending 39 schools in Plateau state, Nigeria. Responses from 2705 students were included in the analysis.ResultsOverall 909 students (34%) reported ever having had sexual intercourse, and 1119 (41%) reported a polygamous family structure. Sexual activity was more common among students from polygamous families (42% of students) than monogamous families (28%) (χ²=64.23; P<0.0001). Variables independently associated with sexual activity were male sex (adjusted odds ratio 2.52 (95% confidence interval 2.05 to 3.12)), older age (1.62 (1.24 to 2.14)), lower sense of connectedness with parents (1.87 (1.48 to 2.38)), having a dead parent (1.59 (1.27 to 2.00)), family polygamy (1.58 (1.29 to 1.92)), lower sense of connectedness with school (1.25 (1.09 to 1.44)), and lower educational level of parents (1.14 (1.05 to 1.24)). Multistep logistic regression analysis showed that the effect of polygamy on sexual activity was reduced by 27% by whether students were married and 22% by a history of forced sex.ConclusionsSecondary school students in Nigeria from a polygamous family structure are more likely to have engaged in sexual activity than students from a monogamous family structure. This effect is partly explained by a higher likelihood of marriage during adolescence and forced sex. Students'' sense of connectedness to their parents and school, regardless of family structure, decreases the likelihood of sexual activity, and fostering this sense may help reduce risky sexual behaviour among Nigerian youth.

What is already known on this topic

In 2000 Nigeria developed a national health policy aimed at preventing behaviour among adolescents leading to sexually transmitted infections (including HIV), pregnancy, and dropout from schoolEffective interventions in Nigeria have been hampered by inadequate information on contextual factors associated with sexual behaviour of adolescentsIn Western countries adolescents'' sense of connectedness to their parents and to school is inversely associated with risky sexual behaviour, but these effects may differ in countries where polygamy is prevalent and where school attendance is low

What this paper adds

A polygamous family structure is associated with early sexual activity among adolescents, an effect partly explained by a higher likelihood of marriage and history of forced sexual intercourseA greater sense of connectedness to parents and school decreases the likelihood of sexual activity, regardless of family structure     

Sexual Risk Reduction for HIV-Infected Persons: A Meta-Analytic Review of “Positive Prevention” Randomized Clinical Trials

Background

Prevention intervention trials have been conducted to reduce risk of sexual transmission among people living with HIV/AIDS (PLWHA), but the findings were inconsistent. We performed a systematic review and meta-analysis to evaluate overall efficacy of prevention interventions on unprotected vaginal or anal intercourse (UVAI) among PLWHA from randomized clinical trials (RCTs).

Methods

RCTs of prevention interventions among PLWHA published as of February 2012 were identified by systematically searching thirteen electronic databases. The primary outcome was UVAI. The difference of standardized mean difference (SMD) of UVAI between study arms, defined as effect size (ES), was calculated for each study and then pooled across studies using standard meta-analysis with a random effects model.

Results

Lower likelihood of UVAI was observed in the intervention arms compared with the control arms either with any sexual partners (mean ES: −0.22; 95% confidence interval [CI]: −0.32, −0.11) or with HIV-negative or unknown-status sexual partners (mean ES and 95% CI: −0.13 [−0.22, −0.04]). Short-term efficacy of interventions with ≤10 months of follow up was significant in reducing UVAI (1–5 months: −0.27 [−0.45, −0.10]; 6–10 months: −0.18 [−0.30, −0.07]), while long-term efficacy of interventions was weaker and might have been due to chance (11–15 months: −0.13 [−0.34, 0.08]; >15 months: −0.05 [−0.43, 0.32]).

Conclusions

Our meta-analyses confirmed the short-term impact of prevention interventions on reducing self-reported UVAI among PLWHA irrespective of the type of sexual partner, but did not support a definite conclusion on long-term effect. It is suggested that booster intervention sessions are needed to maintain a sustainable reduction of unprotected sex among PLWHA in future risk reduction programs.     

Men Who Have Sex with Men (MSM) and Factors Associated with Not Using a Condom at Last Sexual Intercourse with a Man and with a Woman in Senegal

Background

Men who have sex with other men (MSM) are a vulnerable population in Africa that has been insufficiently explored. Given the high rate of bisexuality among MSM (73% in the past year), it is important to understand their risk-taking behaviors regarding both men and women.

Methodology/Principal Findings

A socio-behavioral survey was carried out in 2007 among 501 MSM recruited using the snowball sampling method. We explore in this article why a condom was not used during last sexual intercourse with a man and with a woman, taking into account the respondent''s characteristics, type of relationship and the context of the sexual act. In the survey, 489 men reported that they had had sexual intercourse at least once with another man during the previous year, and 358 with a man and with a woman. The main risk factors for not using a condom at last sexual intercourse with another man were having sex in a public place (aOR = 6.26 [95%CI: 2.71–14.46]), non-participation in an MSM prevention program (aOR = 3.47 [95%CI: 2.12–5.69]), a 19 years old or younger partner (aOR = 2.6 [95%CI: 1.23–4.53]), being 24 years or younger (aOR = 2.07 [95%CI: 1.20–3.58]) or being 35 years or over (aOR = 3.08 [95%CI:1.11–8.53]) and being unemployed (aOR = 0.36 [95%CI: 0.10–1.25]). The last sexual intercourse with the respondent''s wife was hardly ever protected (2%). With women, the other factors were a 15 years or younger partner (aOR = 6.45 [95%CI: 2.56–16.28]), being educated (primary: aOR = 0.45 [95%CI: 0.21–0.95], secondary or higher: aOR = 0.26 [95%CI: 0.11–0.62]), being a student (aOR = 2.20 [95%CI: 1.07–4.54]) or unemployed (aOR = 3.72 [95%CI: 1.31–10.61]) and having participated in a MSM prevention program (aOR = 0.57 [95%CI: 0.34–0.93]).

Conclusion

Having participated in a prevention program specifically targeting MSM constitutes a major prevention factor. However, these programs targeting MSM must address their heterosexual practices and the specific risks involved.     

Open randomised trial of intermittent very low energy diet together with nicotine gum for stopping smoking in women who gained weight in previous attempts to quit

ObjectiveTo determine whether attempts to prevent weight gain will increase success rates for stopping smoking.Design16 week, open, randomised study with 1 year follow up.SettingObesity unit.Subjects287 female smokers who had quit smoking before but started again because of weight concerns.InterventionCombination of a standard smoking cessation programme with nicotine gum and a behavioural weight control programme including a very low energy diet. A control group was treated with the identical programme but without the diet.ResultsAfter 16 weeks, 68/137 (50%) women had stopped smoking in the diet group versus 53/150 (35%) in the control group (P=0.01). Among these women, weight fell by mean 2.1 (95% confidence interval 2.9 to 1.3) kg in the diet group but increased by 1.6 (0.9 to 2.3) kg in the control group (P<0.001). After 1 year the success rates in the diet and control groups were 38/137 (28%) and 24/150 (16%) respectively (P<0.05), but there was no statistical difference in weight gain.ConclusionsCombining the smoking cessation programme with an intervention to control weight helped women to stop smoking and control weight.     

Efficacy,tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials

ObjectiveTo determine the efficacy, gastrointestinal safety, and tolerability of celecoxib (a cyclo-oxygenase 2 (COX 2) inhibitor) used in the treatment of osteoarthritis and rheumatoid arthritis.DesignSystematic review of randomised trials that compared at least 12 weeks'' celecoxib treatment with another non-steroidal anti-inflammatory drug (NSAID) or placebo and reported efficacy, tolerability, or safety. Trials identified from manufacturer and by searching electronic databases and evaluated according to predefined inclusion and quality criteria. Data combined through meta-analysis.Participants15 187 patients with osteoarthritis or rheumatoid arthritis.ResultsNine randomised controlled trials were included. Celecoxib and NSAIDS were equally effective for all efficacy outcomes. Compared with those taking other NSAIDs, in patients taking celecoxib the rate of withdrawals due to adverse gastrointestinal events was 46% lower (95% confidence interval 29% to 58%; NNT 35 at three months), the incidence of ulcers detectable by endoscopy was 71% lower (59% to 79%; NNT 6 at three months), and the incidence of symptoms of ulcers, perforations, bleeds, and obstructions was 39% lower (4% to 61%; NNT 208 at six months). Subgroup analysis of patients taking aspirin showed that the incidence of ulcers detected by endoscopy was reduced by 51% (14% to 72%) in those given celecoxib compared with other NSAIDs. The reduction was greater (73%, 52% to 84%) in those not taking aspirin.ConclusionCelecoxib is as effective as other NSAIDs for relief of symptoms of osteoarthritis and rheumatoid arthritis and has significantly improved gastrointestinal safety and tolerability.

What is already known on this topic

Long term NSAID use is associated with the development of peptic and duodenal ulcersCOX 2 specific inhibitors are claimed to cause fewer gastrointestinal complicationsThe National Institute for Clinical Excellence has recently recommended that COX 2 specific inhibitors are used in patients with arthritis who are at risk of gastrointestinal complications but not in those taking prophylactic aspirin

What this study adds

Systematic review of randomised trials shows that celecoxib is as effective as other NSAIDs for osteoarthritis and rheumatoid arthritisCelecoxib has significantly improved gastrointestinal safety and tolerability compared with standard NSAIDsAn improvement in gastrointestinal safety was still evident in patients who were also taking aspirin     

Long-Term Biological and Behavioural Impact of an Adolescent Sexual Health Intervention in Tanzania: Follow-up Survey of the Community-Based MEMA kwa Vijana Trial

Background

The ability of specific behaviour-change interventions to reduce HIV infection in young people remains questionable. Since January 1999, an adolescent sexual and reproductive health (SRH) intervention has been implemented in ten randomly chosen intervention communities in rural Tanzania, within a community randomised trial (see below; {"type":"clinical-trial","attrs":{"text":"NCT00248469","term_id":"NCT00248469"}}NCT00248469). The intervention consisted of teacher-led, peer-assisted in-school education, youth-friendly health services, community activities, and youth condom promotion and distribution. Process evaluation in 1999–2002 showed high intervention quality and coverage. A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 (HSV-2) seroprevalence but found substantial improvements in SRH knowledge, reported attitudes, and some reported sexual behaviours. It was postulated that the impact on “upstream” knowledge, attitude, and reported behaviour outcomes seen at the 3-year follow-up would, in the longer term, lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes. A further impact evaluation survey in 2007/8 (∼9 years post-intervention) tested this hypothesis.

Methods and Findings

This is a cross-sectional survey (June 2007 through July 2008) of 13,814 young people aged 15–30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial (1999–2002). Prevalences of the primary outcomes HIV and HSV-2 were 1.8% and 25.9% in males and 4.0% and 41.4% in females, respectively. The intervention did not significantly reduce risk of HIV (males adjusted prevalence ratio [aPR] 0.91, 95%CI 0.50–1.65; females aPR 1.07, 95%CI 0.68–1.67) or HSV-2 (males aPR 0.94, 95%CI 0.77–1.15; females aPR 0.96, 95%CI 0.87–1.06). The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime (aPR 0.87, 95%CI 0.78–0.97) and an increase in reported condom use at last sex with a non-regular partner among females (aPR 1.34, 95%CI 1.07–1.69). There was a clear and consistent beneficial impact on knowledge, but no significant impact on reported attitudes to sexual risk, reported pregnancies, or other reported sexual behaviours. The study population was likely to have been, on average, at lower risk of HIV and other sexually transmitted infections compared to other rural populations, as only youth who had reached year five of primary school were eligible.

Conclusions

SRH knowledge can be improved and retained long-term, but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence. Youth interventions integrated within intensive, community-wide risk reduction programmes may be more successful and should be evaluated.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00248469","term_id":"NCT00248469"}}NCT00248469 Please see later in the article for the Editors'' Summary     

Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial

ObjectiveTo determine the effectiveness of multifactorial intervention after a fall in older patients with cognitive impairment and dementia attending the accident and emergency department.DesignRandomised controlled trial.Participants274 cognitively impaired older people (aged 65 or over) presenting to the accident and emergency department after a fall: 130 were randomised to assessment and intervention and 144 were randomised to assessment followed by conventional care (control group).SettingTwo accident and emergency departments, Newcastle upon Tyne.ResultsIntention to treat analysis showed no significant difference between intervention and control groups in proportion of patients who fell during 1 year''s follow up (74% (96/130) and 80% (115/144), relative risk ratio 0.92, 95% confidence interval 0.81 to 1.05). No significant differences were found between groups for secondary outcome measures.ConclusionsMultifactorial intervention was not effective in preventing falls in older people with cognitive impairment and dementia presenting to the accident and emergency department after a fall.

What is already known on this topic

Multifactorial intervention prevents falls in cognitively normal older people living in the community and in those who present to the accident and emergency department after a fallFall prevention strategies have not been tested by controlled trials in patients with cognitive impairment and dementia who fall

What this study adds

No benefit was shown from multifactorial assessment and intervention after a fall in patients with cognitive impairment and dementia presenting to the accident and emergency departmentThe intervention was less effective in these patients than in cognitively normal older people     

Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial

Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes.Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level.Setting 207 general practices in 13 primary care sites in the United Kingdom.Participants 824 adults (55% men, mean age 59.5 years).Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care.Main outcome measures Haemoglobin A_1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months.Main results Haemoglobin A_1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval −0.10% to 0.20%). The intervention group showed a greater weight loss: −2.98 kg (95% confidence interval −3.54 to −2.41) compared with 1.86 kg (−2.44 to −1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was −0.50 (95% confidence interval −0.96 to −0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008).Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A_1c levels up to 12 months after diagnosis.Trial registration Current Controlled Trials ISRCTN17844016.     

Cross sectional survey of effectiveness of lipid lowering drugs in reducing serum cholesterol concentration in patients in 17 general practices

ObjectiveTo compare the effectiveness of lipid lowering drugs in lowering serum cholesterol concentrations.DesignCross sectional study.Setting17 practices within 17 primary care groups in Trent region, United Kingdom.ParticipantsPatients aged 35 years or over taking lipid lowering drugs and with at least two serum cholesterol concentrations recorded on computer.Results1353 of 2469 (54.8%) patients receiving lipid lowering treatment had a last recorded serum cholesterol concentration of ⩽5 mmol/l. Significantly more patients taking statins achieved the target value for serum cholesterol (5 mmol/l) than those taking fibrates (1307 (57%) v 46 (26%); P<0.0001). Atorvastatin and simvastatin were the most effective drugs in achieving the target. Significant differences were found between lipid lowering drugs for the pretreatment serum cholesterol concentration, the most recent cholesterol concentration, and the associated percentage reduction. Atorvastatin and simvastatin achieved the greatest percentage reduction in serum cholesterol concentrations (30.1%, 95% confidence interval 28.8% to 31.4%, and 28.0%, 26.7% to 29.3%, respectively). Although the mean serum cholesterol concentrations in this unselected population tended to be higher than those in clinical trials, the percentage reduction was consistent with the trials.ConclusionThe ability of individual statins to lower serum cholesterol concentration varied, with atorvastatin and simvastatin being the most effective. The percentage reductions agreed with those of randomised controlled trials indicating likely benefits in unselected patients in primary care. As the initial serum cholesterol concentrations were higher than those in randomised controlled trials, target serum cholesterol values of ⩽5 mmol/l may be unrealistic even for patients taking the most efficacious drugs. Also, the higher initial levels could mean that the absolute reduction in cardiovascular risk in primary care patients is greater than thought.

What is already known on this topic

Statins in patients with coronary heart disease help reduce further cardiovascular events and improve survivalThis seems to be a class effect of statins, although there may be important differences in effectiveness between themLess than half of patients in the community who take lipid lowering drugs achieve target serum cholesterol values

What this study adds

Statins vary in their ability to lower serum cholesterol concentration, with atorvastatin and simvastatin achieving the best resultsThe percentage reductions agreed with those found in randomised controlled trialsSince the initial serum cholesterol concentrations were higher than in trials, absolute risk reductions in primary care patients may be greater than thoughtTarget values of ⩽5 mmol/l may be unrealistic even for patients on the most efficacious drugs, because the initial mean cholesterol values of primary care patients are higher than those of patients in trials     

Dihydroartemisinin-Piperaquine and Artemether-Lumefantrine for Treating Uncomplicated Malaria in African Children: A Randomised,Non-Inferiority Trial

Background

Artemisinin combination therapies (ACTs) are currently the preferred option for treating uncomplicated malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children.

Methodology/Principal Findings

The non-inferiority of DHA-PQP versus artemether-lumefantrine (AL) in children 6–59 months old with uncomplicated P. falciparum malaria was tested in five African countries (Burkina Faso, Kenya, Mozambique, Uganda and Zambia). Patients were randomised (2∶1) to receive either DHA-PQP or AL. Non-inferiority was assessed using a margin of −5% for the lower limit of the one-sided 97.5% confidence interval on the treatment difference (DHA-PQP vs. AL) of the day 28 polymerase chain reaction (PCR) corrected cure rate. Efficacy analysis was performed in several populations, and two of them are presented here: intention-to-treat (ITT) and enlarged per-protocol (ePP). 1553 children were randomised, 1039 receiving DHA-PQP and 514 AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and 94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3% (ePP) in the AL group. The lower limits of the one-sided 97.5% CI of the difference between the two treatments were −2.80% and −2.96%, in the ITT and ePP populations, respectively. In the ITT population, the Kaplan-Meier estimate of the proportion of new infections up to Day 42 was 13.55% (95% CI: 11.35%–15.76%) for DHA-PQP vs 24.00% (95% CI: 20.11%–27.88%) for AL (p<0.0001).

Conclusions/Significance

DHA-PQP is as efficacious as AL in treating uncomplicated malaria in African children from different endemicity settings, and shows a comparable safety profile. The occurrence of new infections within the 42-day follow up was significantly lower in the DHA-PQP group, indicating a longer post-treatment prophylactic effect.

Trial Registration

Controlled-trials.com ISRCTN16263443     

Insecticide impregnated curtains to control domestic transmission of cutaneous leishmaniasis in Venezuela: cluster randomised trial

ObjectiveTo measure the impact on transmission of leishmaniasis of curtains impregnated with insecticide.DesignCluster randomised controlled trial: household interview survey, observational study of people''s behaviour, entomological study with light trap captures of sandflies inside houses.Setting14 urban sectors in Trujillo, Venezuela.Participants2913 inhabitants of 569 houses.InterventionSectors were paired according to their 12 month cumulative incidence of cutaneous leishmaniasis, one sector in each pair was randomly allocated to receive polyester curtains impregnated with lambdacyhalothrin (intervention group) while the other sector received curtains without insecticide or no curtains (control groups). After 12 months a follow up household survey was conducted.ResultsTransmission of cutaneous leishmaniasis occurred mainly in the domestic setting, with the incidence over 12 months of 4%. The mean number of sandflies per trap per night was 16. After follow up the 12 month incidence of cutaneous leishmaniasis was 0% in the intervention group and 8% in the six pairs in the control group that received unimpregnated curtains (mean difference 8, 95% confidence interval 4.22 to 11.78; P=0.001). There were significantly fewer sandflies in the intervention group (2 v 15, mean difference 13 sandflies per trap; 9 to 17; P<0.001).ConclusionCurtains impregnated with insecticide provide a high degree of protection against indoor transmission of cutaneous leishmaniasis.

What is already known on this topic

The transmission of cutaneous leishmaniasis is increasingly in urban and domestic settingsHouse spraying, space spraying, and insecticide treated material reduce the number of vectors

What this paper adds

Pyrethroid impregnated curtains can considerably reduce the incidence rate of cutaneous leishmaniasis in areas where indoor transmission is predominant     

Sexual Seroadaptation: Lessons for Prevention and Sex Research from a Cohort of HIV-Positive Men Who Have Sex with Men

Background

Surveillance data on sexually transmitted infections (STIs) and behavioral characteristics identified in studies of the risk of seroconversion are often used as to track sexual behaviors that spread HIV. However, such analyses can be confounded by “seroadaptation”—the restriction of unprotected anal intercourse (UAI), especially unprotected insertive UAI, to seroconcordant partnerships.

Methods

We utilized sexual network methodology and repeated-measures statistics to test the hypothesis that seroadaptive strategies reduce the risk of HIV transmission despite numerous partnerships and frequent UAI.

Principal Findings

In a prospective cohort study of HIV superinfection including 168 HIV-positive men who have sex with men (MSM), we found extensive seroadaptation. UAI was 15.5 times more likely to occur with a positive partner than a negative one (95% confidence interval [CI], 9.1–26.4). Receptive UAI was 4.3 times more likely in seroconcordant partnerships than with negative partners (95% CI, 2.8–6.6), but insertive UAI was 13.6 times more likely with positives (95% CI, 7.2–25.6). Our estimates suggest that seroadaptation reduced HIV transmissions by 98%.

Conclusion

Potentially effective HIV prevention strategies, such as seroadaptation, have evolved in communities of MSM before they have been recognized in research or discussed in the public health forum. Thus, to be informative, studies of HIV risk must be designed to assess seroadaptive behaviors rather than be limited to individual characteristics, unprotected intercourse, and numbers of partners. STI surveillance is not an effective indicator of trends in HIV incidence where there are strong patterns of seroadaptation.     

β Blockade after myocardial infarction: systematic review and meta regression analysis

ObjectivesTo assess the effectiveness of β blockers in short term treatment for acute myocardial infarction and in longer term secondary prevention; to examine predictive factors that may influence outcome and therefore choice of drug; and to examine the clinical importance of the results in the light of current treatment.DesignSystematic review of randomised controlled trials.SettingRandomised controlled trials.SubjectsPatients with acute or past myocardial infarction.Interventionβ Blockers compared with control.Mainoutcome measures All cause mortality and non-fatal reinfarction.ResultsOverall, 5477 of 54 234 patients (10.1%) randomised to β blockers or control died. We identified a 23% reduction in the odds of death in long term trials (95% confidence interval 15% to 31%), but only a 4% reduction in the odds of death in short term trials (−8% to 15%). Meta regression in long term trials did not identify a significant reduction in effectiveness in drugs with cardioselectivity but did identify a near significant trend towards decreased benefit in drugs with intrinsic sympathomimetic activity. Most evidence is available for propranolol, timolol, and metoprolol. In long term trials, the number needed to treat for 2 years to avoid a death is 42, which compares favourably with other treatments for patients with acute or past myocardial infarction.Conclusionsβ Blockers are effective in long term secondary prevention after myocardial infarction, but they are underused in such cases and lead to avoidable mortality and morbidity.

Key messages

• The first randomised trials of β blockade in secondary prevention after myocardial infarction were published in the 1960s
• β blockers were once heralded as a major advance, but their use for secondary prevention has declined in recent years
• Firm evidence shows that long term β blockade remains an effective and well tolerated treatment that reduces mortality and morbidity in unselected patients after myocardial infarction
• The benefits from β blockade compare favourably with other drug treatments for this patient group
• Most evidence is for propranolol, timolol, and metoprolol, whereas atenolol, which is commonly used, is inadequately evaluated for long term use

     

An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group

Background

Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.

Methods and Findings

Participants (n = 1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.

Conclusions

These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00153361","term_id":"NCT00153361"}}NCT00153361 Please see later in the article for the Editors'' Summary