Articles tagged as "Biomedical interventions and prevention tools"

Promising results from a combination HIV prevention strategy for MSM in Central America

Effectiveness of a combination prevention strategy for HIV risk reduction with men who have sex with men in Central America: a mid-term evaluation.

Firestone R, Rivas J, Lungo S, Cabrera A, Ruether S, Wheeler J, Vu L. BMC Public Health. 2014 Dec 4;14:1244. doi: 10.1186/1471-2458-14-1244.

Background: Despite over a decade of research and programming, little evidence is available on effective strategies to reduce HIV risks among Central American men who have sex with men (MSM). The Pan-American Social Marketing Organization (PASMO) and partners are implementing a HIV Combination Prevention Program to provide key populations with an essential package of prevention interventions and services: 1) behavioral, including interpersonal communications, and online outreach; 2) biomedical services including HIV testing and counseling and screening for STIs; and 3) complementary support, including legal support and treatment for substance abuse. Two years into implementation, we evaluated this program's effectiveness for MSM by testing whether exposure to any or a combination of program components could reduce HIV risks.

Methods: PASMO surveyed MSM in 10 cities across Guatemala, El Salvador, Nicaragua, Costa Rica, and Panama in 2012 using respondent-driven sampling. We used coarsened exact matching to create statistically equivalent groups of men exposed and non-exposed to the program, matching on education, measures of social interaction, and exposure to other HIV prevention programs. We estimated average treatment effects of each component and all combined to assess HIV testing and condom use outcomes, using multivariable logistic regression. We also linked survey data to routine service data to assess program coverage.

Results: Exposure to any program component was 32% in the study area (n = 3531). Only 2.8% of men received all components. Men exposed to both behavioral and biomedical components were more likely to use condoms and lubricant at last sex (AOR 3.05, 95% CI 1.08, 8.64), and those exposed to behavioral interventions were more likely to have tested for HIV in the past year (AOR 1.76, 95% CI 1.01, 3.10).

Conclusions: PASMO's strategies to reach MSM with HIV prevention programming are still achieving low levels of population coverage, and few men are receiving the complete essential package. However, those reached are able to practice HIV prevention. Combination prevention is a promising approach in Central America, requiring expansion in coverage and intensity.

Abstract  Full-text [free] access

Editor’s notes: In countries where same-sex behaviour is criminalised and/or highly stigmatised, men who have sex with men (MSM) often find it very difficult to obtain appropriate sexual health services.  Such difficulties contribute to the continued high prevalence of HIV among MSM in some settings.  Strategies to prevent HIV transmission, increasingly favour a combination of activities which aim to reflect specific social conditions. It is important that these complex prevention programmes are systematically evaluated. This paper discusses one of the first evaluations of a combined HIV prevention strategy including behavioural, biomedical and psychosocial components. The strategy is aimed specifically at MSM in Central America, among whom the authors note that HIV prevalence ranges from 7.5% to 11.1%. About one-third of MSM participants in respondent-driven samples, reported exposure to at least one component of the programme during the two years of implementation. But few, three percent, received all three components, reflecting the hard-to-reach nature of the population as well as programmatic issues. Despite the modest coverage, there was some evidence that the programme was associated with reported risk reduction and HIV testing uptake. The study provides promising results, but highlights the need to tackle stigmatisation and social exclusion of MSM in this region, to enable prevention strategies to be effective at scale.

Latin America
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Longitudinal study illustrates link between alcohol use, traumatic stress and risk of HIV

Traumatic stress and the mediating role of alcohol use on HIV-related sexual risk behavior: Results from a longitudinal cohort of South African women who attend alcohol-serving venues.

Abler L, Sikkema KJ, Watt MH, Pitpitan EV, Kalichman SC, Skinner D, Pieterse D. J Acquir Immune Defic Syndr. 2014 Nov 12. [Epub ahead of print]

Background: In South Africa, alcohol contributes to the HIV epidemic, in part, by influencing sexual behaviors. For some, high levels of alcohol consumption may be driven by previous traumatic experiences that result in traumatic stress. The purpose of this study was to quantify the longitudinal association between traumatic stress and unprotected sex among women who attend drinking venues and to assess whether this association was explained by mediation through alcohol use.

Methods: Data were collected in four waves over a year from a prospective cohort of 560 women who regularly attended alcohol-serving venues in a Cape Town township. Longitudinal mixed models examined: 1) the relationship between traumatic stress and counts of unprotected sex, and 2) whether alcohol use mediated the association between traumatic stress and unprotected sex.

Results: Most women reported elevated traumatic stress (80%) and hazardous alcohol use (88%) at least once during the study period. In models adjusted for covariates, traumatic stress was associated with unprotected sex (b=0.28, SE=0.06, t=4.82, p<.001). In addition, traumatic stress was associated with alcohol use (b=0.27, SE=0.02, t=14.25, p<.001), and was also associated with unprotected sex (b=0.20, SE=0.06, t=3.27, p<.01) while controlling for alcohol use (b=0.28, SE=0.07, t=4.25, p<.001). The test for the mediated effect established that alcohol use was a significant mediator, accounting for 27% of the total effect of traumatic stress on unprotected sex.

Conclusions: These results highlight the need to address traumatic stress among female venue patrons as an important precursor of HIV risk due to alcohol use.

Abstract access

Editor’s notes: There is an established link between alcohol use and high-risk sexual behaviour, but the role of mental health in this relationship is often overlooked. Traumatic stress can lead to problematic drinking patterns and increased high-risk sexual behaviour. These negative coping mechanisms may in turn increase traumatic stress, further elevating the risk of HIV infection. A longitudinal cohort study of 560 South African women was conducted to quantify this association. The study benefits from a large sample size and good participant retention throughout the study period.

Traumatic stress was measured using a 17-item Post Traumatic Stress Disorder checklist (PCL) and alcohol use was measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). The primary outcome was the number of unprotected sexual events that participants reported having in the previous four months. Participants who scored higher for traumatic stress and alcohol use reported having more unprotected sex. Traumatic stress was also found to be independently associated with alcohol use. These findings provide support for programmes that focus on both alcohol use and traumatic stress, owing to their tendency to co-occur and heighten the risk of HIV infection. The authors recommend adapting such programmes to the South African setting and call for further research into how best to identify women at risk of traumatic stress in South African drinking venues.

Africa
South Africa
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Modelling combination prevention for men who have sex with men in South Africa: strategies for success

Combination HIV prevention among MSM in South Africa: results from agent-based modeling.

Brookmeyer R, Boren D, Baral SD, Bekker LG, Phaswana-Mafuya N, Beyrer C, Sullivan PS. PLoS One. 2014 Nov 14;9(11):e112668. doi: 10.1371/journal.pone.0112668. eCollection 2014.

HIV prevention trials have demonstrated the effectiveness of a number of behavioral and biomedical interventions. HIV prevention packages are combinations of interventions and offer potential to significantly increase the effectiveness of any single intervention. Estimates of the effectiveness of prevention packages are important for guiding the development of prevention strategies and for characterizing effect sizes before embarking on large scale trials. Unfortunately, most research to date has focused on testing single interventions rather than HIV prevention packages. Here we report the results from agent-based modeling of the effectiveness of HIV prevention packages for men who have sex with men (MSM) in South Africa. We consider packages consisting of four components: antiretroviral therapy for HIV infected persons with CD4 count <350; PrEP for high risk uninfected persons; behavioral interventions to reduce rates of unprotected anal intercourse (UAI); and campaigns to increase HIV testing. We considered 163 HIV prevention packages corresponding to different intensity levels of the four components. We performed 2252 simulation runs of our agent-based model to evaluate those packages. We found that a four component package consisting of a 15% reduction in the rate of UAI, 50% PrEP coverage of high risk uninfected persons, 50% reduction in persons who never test for HIV, and 50% ART coverage over and above persons already receiving ART at baseline, could prevent 33.9% of infections over 5 years (95% confidence interval, 31.5, 36.3). The package components with the largest incremental prevention effects were UAI reduction and PrEP coverage. The impact of increased HIV testing was magnified in the presence of PrEP. We find that HIV prevention packages that include both behavioral and biomedical components can in combination prevent significant numbers of infections with levels of coverage, acceptance and adherence that are potentially achievable among MSM in South Africa.

Abstract Full-text [free] access

Editor’s notes: The HIV epidemic among men who have sex with men (MSM) in sub-Saharan Africa continues to grow and focused prevention efforts are needed for this population. This is one the first studies to model the effectiveness of a combination HIV prevention study among MSM, and one of few modelling studies among MSM in Africa. This paper finds that a potentially achievable combination package of increased HIV testing, condom use, PrEP and antiretroviral therapy could prevent about a third of new infections over the next five years. The component with the largest incremental impact on infections was the behavioural component. This resulted in a 15% reduction in unprotected anal intercourse. This finding emphasises the need for renewed efforts to reinforce behavioural approaches to HIV prevention, which also have lower resource requirements than the biomedical components included in these models. Further work on understanding associations with regard to uptake and adherence to programmes among MSM in sub-Saharan Africa would be very useful to help design focused programme packages.

Africa
South Africa
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Diagnosis of syphilis as an entry point for PrEP initiation among men who have sex with men

Syphilis predicts HIV incidence among men and transgender women who have sex with men in a preexposure prophylaxis trial.

Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, Fernandez T, Grant RM, iPrEx Study Team. Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.

Background: Syphilis infection may potentiate transmission of human immunodeficiency virus (HIV). We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis (PrEP) trial and whether emtricitabine/tenofovir (FTC/TDF) modified that association.

Methods: The Preexposure Prophylaxis Initiative (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily FTC/TDF or placebo. Syphilis prevalence at screening and incidence during follow-up were measured. Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated. The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed.

Results: Of 2499 individuals, 360 (14.4%) had a positive rapid plasma reagin test at screening; 333 (92.5%) had a positive confirmatory test, which did not differ between the arms (FTC/TDF vs placebo, P = .81). The overall syphilis incidence during the trial was 7.3 cases per 100 person-years. There was no difference in syphilis incidence between the study arms (7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo, P = .304). HIV incidence varied by incident syphilis (2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis), reflecting a hazard ratio of 2.6 (95% confidence interval, 1.6-4.4; P < .001). There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence.

Conclusions: In HIV-seronegative MSM, syphilis infection was associated with HIV acquisition in this PrEP trial; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated.

Abstract  Full-text [free] access

Editor’s notes: The Preexposure Prophylaxis Initiative (iPrEx) trial and other recent trials have illustrated clearly that preexposure prophylaxis (PrEP) with emtricitabine/tenofovir (FTC/TDF) dramatically reduces the risk of HIV when used correctly and consistently. There is current discussion about the practical implications of these findings. This paper confirms a strong association between incident syphilis and HIV acquisition among men who have sex with men (MSM), and illustrates that syphilis did not attenuate the protective benefit of FTC/TDF against HIV. Syphilis continues to be prevalent among MSM in many settings, and the screening prevalence of 13% in this study is consistent with global estimates. These results highlight that individuals with syphilis are a key group for HIV acquisition. The results suggest that a new diagnosis of syphilis is an important opportunity for PrEP initiation, unless contraindications are present. This would be in addition to immediate syphilis treatment, and treatment for sexual partners. 

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Cervical cancer screening programmes in resource-limited settings

Clinical performance of digital cervicography and cytology for cervical cancer screening in HIV-infected women in Lusaka, Zambia.

Bateman AC, Parham GP, Sahasrabuddhe VV, Mwanahamuntu MH, Kapambwe S, Katundu K, Nkole T, Mulundika J, Pfaendler KS, Hicks ML, Shibemba A, Vermund SH, Stringer JS, Chibwesha. J Acquir Immune Defic Syndr. 2014 Oct 1;67(2):212-5. doi: 10.1097/QAI.0000000000000270.

Although there is a growing literature on the clinical performance of visual inspection with acetic acid in HIV-infected women, to the best of our knowledge, none have studied visual inspection with acetic acid enhanced by digital cervicography. We estimated clinical performance of cervicography and cytology to detect cervical intraepithelial neoplasia grade 2 or worse. Sensitivity and specificity of cervicography were 84% (95% confidence interval [CI]: 72 to 91) and 58% (95% CI: 52 to 64). At the high-grade squamous intraepithelial lesion or worse cutoff for cytology, sensitivity and specificity were 61% (95% CI: 48 to 72) and 58% (95% CI: 52 to 64). In our study, cervicography seems to be as good as cytology in HIV-infected women.

Abstract access 

Editor’s notes: Cervical cancer is the most common female malignancy in sub-Saharan Africa and the leading cause of cancer-related mortality. Women living with HIV have a higher incidence and prevalence of infection with human papilloma virus (HPV), and are less able to clear the virus. Persistence of high-risk types of HPV infection is a prerequisite for development of cervical cancer. In high-income countries, screening programmes which incorporate regular cervical cytology (one to five yearly) to detect pre-cancerous lesions, have reduced mortality; however cytology is labour intensive and technically challenging. As a result cervical screening is not widely available in resource-limited settings. Alternative screening strategies, including visual inspection with acetic acid (VIA) with onward referral for colposcopy if abnormal lesions are visualised, are practiced in some settings, although coverage is low.

This study reports on the sensitivity and specificity of VIA enhanced by digital photography. The addition of digital photography allows magnification of surface morphology, and facilitates telemedicine support and quality assurance of screening programmes.  All individuals had cytology, VIA, photographs and biopsies taken at the same visit. Cervical biopsies were taken from the abnormal area and from a normal area of the transformation zone with the gold standard defined as cervical intraepithelial neoplasia grade 2or 3 or adenocarcinoma in situ (CIN2+) lesion on histopathology of either site. VIA with digital photography had a higher sensitivity than cytology (84% and 61% respectively) but specificity was low with both techniques (58% each). Results are broadly comparable to those reported from other studies evaluating VIA in women living with HIV. This approach is certainly more feasible to implement in resource-limited settings and if programme coverage is high, may impact on mortality. However, given the low specificity, over-treatment is likely. As the authors illustrate there is definitely a need to develop other screening strategies based on point-of-care biomarkers if we are to see a significant impact on mortality due to cervical cancer in resource-limited settings.

Avoid TB deaths
Africa
Zambia
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Mefloquine not suitable as intermittent preventive treatment of malaria, in pregnant women living with HIV

Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial.

Gonzalez R, Desai M, Macete E, Ouma P, Kakolwa MA, Abdulla S, Aponte JJ, Bulo H, Kabanywanyi AM, Katana A, Maculuve S, Mayor A, Nhacolo A, Otieno K, Pahlavan G, Ruperez M, Sevene E, Slutsker L, Vala A, Williamsom J, Menendez C. PLoS Med. 2014 Sep 23;11(9):e1001735. doi: 10.1371/journal.pmed.1001735. eCollection 2014.

Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ) in women receiving CTXp and long-lasting insecticide treated nets (LLITNs).

Methods and findings: A total of 1071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg) or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27-0.82]; p = 0.008), placental malaria (RR, 0.52 [95% CI 0.29-0.90]; p = 0.021), and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37-0.95]; p = 0.031) in the intention to treat (ITT) analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration). HIV viral load at delivery was higher in the MQ group compared to the control group (p = 0.048) in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14-3.33]; p = 0.015). The main limitation of the latter finding relates to the exploratory nature of this part of the analysis.

Conclusions: An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with better tolerability to reduce malaria in this particularly vulnerable group. MQ was associated with an increased risk of mother to child transmission of HIV, which warrants a better understanding of the pharmacological interactions between antimalarials and antiretroviral drugs.

Abstract  Full-text [free] access

Editor’s notes: The gold standard for intermittent preventive treatment of malaria in pregnancy (IPTp) is at least three doses of sulfadoxine-pyrimethamine, along with the use of insecticide-treated nets. In resource-limited, high HIV prevalent areas, all HIV-positive pregnant women are recommended to take co-trimoxazole prophylaxis. This rules out the concomitant use of sulfadoxine-pyrimethamine because of the increased risk of drug toxicity. However, the effectiveness of co-trimoxazole alone to prevent malaria in pregnant women living with HIV has not been established.   

This article reports a randomised double-blind placebo-controlled trial. The trial compares the efficacy of three-monthly doses of mefloquine (a long-acting efficacious antimalarial, considered to be safe throughout pregnancy) with placebo, in pregnant women living with HIV taking daily co-trimoxazole. Women in the mefloquine arm had a reduced risk of maternal malarial parasitaemia, a reduced rate of placental malaria and reduced incidence of non-obstetric hospital admissions. However, mefloquine was poorly tolerated. Unexpectedly, women in the mefloquine arm had a higher HIV viral load at delivery and were more likely to transmit HIV to their child. Since this finding was based on an exploratory, rather than a pre-planned analysis, its validity is uncertain. If other data support this finding, a better understanding of the underlying mechanism (biological/immunological) will be important to inform future alternative drug regimens for pregnant women living with HIV. 

This trial suggests that an effective antimalarial drug combined with co-trimoxazole can offer additional protection against malaria in pregnant women living with HIV, but mefloquine is not the drug of choice for this purpose. 

Avoid TB deaths
Africa
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Engaging with men about microbicides

Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction.

Lanham M, Wilcher R, Montgomery ET, Pool R, Schuler S, Lenzi R, Friedland B. J Int AIDS Soc. 2014 Sep 8;17(3 Suppl 2):19159. doi: 10.7448/IAS.17.3.19159. eCollection 2014.

Introduction: Constructively engaging male partners in women-centred health programs such as family planning and prevention of mother-to-child HIV transmission has resulted in both improved health outcomes and stronger relationships. Concerted efforts to engage men in microbicide use could make it easier for women to access and use microbicides in the future. This paper synthesizes findings from studies that investigated men's role in their partners' microbicide use during clinical trials to inform recommendations for male engagement in women's microbicide use.

Methods: We conducted primary and secondary analyses of data from six qualitative studies implemented in conjunction with microbicide clinical trials in South Africa, Kenya, and Tanzania. The analyses included data from 535 interviews and 107 focus groups with trial participants, male partners, and community members to answer research questions on partner communication about microbicides, men's role in women's microbicide use, and potential strategies for engaging men in future microbicide introduction. We synthesized the findings across the studies and developed recommendations.

Results: The majority of women in steady partnerships wanted agreement from their partners to use microbicides. Women used various strategies to obtain their agreement, including using the product for a while before telling their partners, giving men information gradually, and continuing to bring up microbicides until resistant partners acquiesced. Among men who were aware their partners were participating in a trial and using microbicides, involvement ranged from opposition to agreement/non-interference to active support. Both men and women expressed a desire for men to have access to information about microbicides and to be able to talk with a healthcare provider about microbicides.

Conclusions: We recommend counselling women on whether and how to involve their partners including strategies for gaining partner approval; providing couples' counselling on microbicides so men have the opportunity to talk with providers; and targeting men with community education and mass media to increase their awareness and acceptance of microbicides. These strategies should be tested in microbicide trials, open-label studies, and demonstration projects to identify effective male engagement approaches to include in eventual microbicide introduction. Efforts to engage men must take care not to diminish women's agency to decide whether to use the product and inform their partners.

Abstract  Full-text [free] access

Editor’s notes: Microbicides were initially conceived as being products that would enable women to protect themselves from HIV without prior negotiation with their partners. However, the experience from microbicide trials shows that in general, male partners play an important role in women’s microbicide use. This paper synthesizes the findings from qualitative research conducted as part of trials in east and southern Africa. The findings highlight that men’s responses to products vary widely, and that women use a range of strategies to obtain men’s agreement. The findings show that no one strategy will fit all women’s needs; and that the priority should be to support women’s agency to decide whether to use microbicides, how to introduce the subject with their partners, and ultimately gain their support. Currently different strategies of male engagement are being used within trials. But the positive and negative effects of different approaches – including their effect on partner communication, relationship quality and intimate partner violence - are not being routinely measured. The paper shows the need for further research in microbicide trials, open-label studies, and demonstration projects, not only on how to support women’s ability to access and use products, but to also to help ensure consistent product use, which is crucial to the overall effectiveness of products.

Africa
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Cotrimoxazole appears safe in pregnant women living with HIV, despite poor quality evidence

Safety of cotrimoxazole in pregnancy: a systematic review and meta-analysis.

Ford N, Shubber Z, Jao J, Abrams EJ, Frigati L, Mofenson L. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):512-21. doi: 10.1097/QAI.0000000000000211.

Introduction: Cotrimoxazole is widely prescribed to treat a range of infections, and for HIV-infected individuals it is administered as prophylaxis to protect against opportunistic infections. Some reports suggest that fetuses exposed to cotrimoxazole during early pregnancy may have an increased risk of congenital anomalies. We carried out this systematic review to update the evidence of cotrimoxazole safety in pregnancy.

Methods: Three databases and 1 conference abstract site were searched in duplicate up to October 31, 2013, for studies reporting adverse maternal and infant outcomes among women receiving cotrimoxazole during pregnancy. This search was updated in MEDLINE via PubMed to April 28, 2014. Studies were included irrespective of HIV infection status or the presence of other coinfections. Our primary outcome was birth defects of any kind. Secondary outcomes included spontaneous abortions, terminations of pregnancy, stillbirths, preterm deliveries, and drug-associated toxicity.

Results: Twenty-four studies were included for review. There were 232 infants with congenital anomalies among 4 196 women receiving cotrimoxazole during pregnancy, giving an overall pooled prevalence of 3.5% (95% confidence interval: 1.8% to 5.1%; τ² = 0.03). Three studies reported 31 infants with neural tube defects associated with first trimester exposure to cotrimoxazole, giving a crude prevalence of 0.7% (95% confidence interval: 0.5% to 1.0%) with most data (29 neural tube defects) coming from a single study. The majority of adverse drug reactions were mild. The quality of the evidence was very low.

Conclusions: The findings of this review support continued recommendations for cotrimoxazole as a priority intervention for HIV-infected pregnant women. It is critical to improve data collection on maternal and infant outcomes.

Abstract access 

Editor’s notes: Cotrimoxazole significantly reduces morbidity and increases survival in people living with HIV (including people on antiretroviral therapy) in resource-limited settings.  However, there is some concern of potential human foetal risk when cotrimoxazole is taken during pregnancy. This systematic review found very limited evaluable data on maternal and infant outcomes associated with cotrimoxazole exposure during pregnancy. Cotrimoxazole is likely to be of most benefit in high HIV burden, low-income settings. In this context, the known benefit of treatment outweighs the potential risk to the foetus, in HIV-positive pregnant women.  Importantly, this paper highlights the need for better pregnancy outcome surveillance in women living with HIV, in resource-poor settings, which includes evaluation of exposure to cotrimoxazole and antiretroviral treatment.  

Africa, Asia, Europe, Northern America, Oceania
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Delayed initiation of antiretroviral therapy among people living with HIV in stable partnerships

Delay of antiretroviral therapy initiation is common in east African HIV-infected individuals in serodiscordant partnerships.

Mujugira A, Celum C, Thomas KK, Farquhar C, Mugo N, Katabira E, Bukusi EA, Tumwesigye E, Baeten JM, Partners PrEP Study Team. J Acquir Immune Defic Syndr. 2014 Aug 1;66(4):436-42. doi: 10.1097/QAI.0000000000000192.

Objective: WHO guidance recommends antiretroviral therapy (ART) initiation for all persons with a known HIV-uninfected partner, as a strategy to prevent HIV transmission. Uptake of ART among HIV-infected partners in serodiscordant partnerships is not known, which we evaluated in African HIV serodiscordant couples.

Design: Prospective cohort study.

Methods: Among HIV-infected persons from Kenya and Uganda who had a known heterosexual HIV-uninfected partner, we assessed ART initiation in those who became ART eligible under national guidelines during follow-up. Participants received quarterly clinical and semi-annual CD4 monitoring, and active referral for ART upon becoming eligible.

Results: Of 1 958 HIV-infected ART-eligible partners, 58% were women, and the median age was 34 years. At the first visit when determined to be ART eligible, the median CD4 count was 273 cells per microliter (interquartile range, 221-330), 77% had WHO stage 1 or 2 HIV disease, and 96% were receiving trimethoprim-sulfamethoxazole prophylaxis. The cumulative probabilities of initiating ART at 6, 12, and 24 months after eligibility were 49.9%, 70.0%, and 87.6%, respectively. Younger age [<25 years; adjusted hazard ratio (AHR), 1.39; P = 0.001], higher CD4 count (AHR, 1.95; P < 0.001 for >350 compared with <200 cells/µL), higher education (AHR, 1.25; P < 0.001), and lack of income (AHR, 1.15; P = 0.02) were independent predictors for delay in ART initiation.

Conclusions: In the context of close CD4 monitoring, ART counseling, and active linkage to HIV care, a substantial proportion of HIV-infected persons with a known HIV-uninfected partner delayed ART initiation. Strategies to motivate ART initiation are needed, particularly for younger persons with higher CD4 counts.

 Abstract access 

Editor’s notes: WHO guidance recommends immediate antiretroviral therapy (ART) initiation, at any CD4 count, for people living with HIV in HIV serodiscordant partnerships. This is included in national HIV strategies in many countries. However, we do not yet know whether individuals will be willing to start ART at a time when they are still asymptomatic, knowing they will have to take the drugs for the rest of their lives. In this study of stable HIV-serodiscordant couples in the Partners PrEP trial, about three-quarters of participants initiated ART during follow-up.  Reasons for non-initiation included higher CD4 count, younger age, and lack of income. The implications of this study for initiating treatment at higher CD4 counts, especially in economically challenged contexts, are important. A better understanding of individuals’ reasons for delaying treatment initiation is needed, including strategies for support. With the move towards higher initiation CD4 thresholds, the success of programming treatment activities may rely heavily on thoroughly understanding the desires and motivations of people who are responsible for taking up treatment. 

Africa
Kenya, Uganda
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Food vouchers as an incentive for male circumcision in Kenya

Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial

 

Thirumurthy H, Masters SH, Rao S, Bronson MA, Lanham M, Omanga E, Evens E, Agot K. JAMA. 2014 Aug 20;312(7):703-11. doi: 10.1001/jama.2014.9087.Epub 20 July 2014.

Importance: Novel strategies are needed to increase the uptake of voluntary medical male circumcision (VMMC) in sub-Saharan Africa and enhance the effectiveness of male circumcision as an HIV prevention strategy. 

Objective: To determine whether small economic incentives could increase circumcision prevalence by addressing reported economic barriers to VMMC and behavioral factors such as present-biased decision making.

Design, Setting, and Participants: Randomized clinical trial conducted between June 22, 2013, and February 4, 2014, among 1 504 uncircumcised men aged 25 to 49 years in Nyanza region, Kenya. VMMC services were provided free of charge and participants were randomized to 1 of 3 intervention groups or a control group.

Interventions: Participants in the 3 intervention groups received varying amounts of compensation conditional on undergoing circumcision at 1 of 9 study clinics within 2 months of enrollment. Compensation took the form of food vouchers worth 200 Kenya shillings (approximately US $2.50), 700 Kenya shillings (approximately US $8.75), or 1 200 Kenya shillings (approximately US $15.00), which reflected a portion of transportation costs and lost wages associated with getting circumcised. The control group received no compensation.

Main Outcomes and Measures: VMMC uptake within 2 months.

Results: Analysis of data for 1 502 participants with complete data showed that VMMC uptake within 2 months was higher in the US $8.75 group (6.6%; 95% CI, 4.3%-9.5% [25 of 381]) and the US $15.00 group (9.0%; 95% CI, 6.3%-12.4% [34 of 377]) than in the US $2.50 group (1.9%; 95% CI, 0.8%-3.8% [7 of 374]) and the control group (1.6%; 95% CI, 0.6%-3.5% [6 of 370]). In logistic regression analysis, the US $8.75 group had significantly higher VMMC uptake than the control group (adjusted odds ratio [AOR] 4.3; 95% CI, 1.7-10.7), as did the US $15.00 group (AOR 6.2; 95% CI, 2.6-15.0). Effect sizes for the US $8.75 and US $15.00 groups did not differ significantly (P = .20).

Conclusions and Relevance: Among uncircumcised men in Kenya, compensation in the form of food vouchers worth approximately US $8.75 or US $15.00, compared with lesser or no compensation, resulted in a modest increase in the prevalence of circumcision after 2 months. The effects of more intense promotion or longer implementation require further investigation.

Abstract access 

Editor’s notes: Despite considerable scale-up of voluntary medical male circumcision (VMMC), most countries are short of their targets of 80% circumcision prevalence, and novel demand-creation strategies are needed. This study is the first randomised controlled trial to evaluate the effectiveness of a conditional economic compensation on VMMC, and found that incentives were effective in increasing VMMC uptake in this population. The compensation was given in the form of food vouchers of a value approximating transportation costs plus up to about three days’ wages.  The voucher was given if the participant underwent circumcision at one of the study clinics within two months.  The programme was particularly effective among married and older participants, and men at higher risk of acquiring HIV – these are priority groups for scale-up but have been relatively hard to reach in many settings.  The trial shows that such economic incentives are promising for VMMC by addressing economic barriers to uptake. Further rigorous evaluation of these economic-based activities, and the exploration of innovative ways to use economic incentives, for HIV-related behaviours such as HIV-testing and linkage/retention in care should be considered.

Africa
Kenya
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