Articles tagged as "Biomedical interventions and prevention tools"

No evidence of increased risk behaviours among recently circumcised men

Risk compensation following male circumcision: results from a two-year prospective cohort study of recently circumcised and uncircumcised men in Nyanza province, Kenya 

Westercamp N, Agot K, Jaoko W, Bailey RC. AIDS Behav. 2014 Sep;18(9):1764-75. doi: 10.1007/s10461-014-0846-4. Epub 22 July 2014.

We present the results of the first study of longitudinal change in HIV-associated risk behaviors in men before and after circumcision in the context of a population-level voluntary medical male circumcision (VMMC) program. The behaviors of 1 588 newly circumcised men and 1 598 age-matched uncircumcised controls were assessed at baseline, 6, 12, 18 and 24 months of follow-up. Despite the precipitous decline in perception of high HIV risk among circumcised men (30-14 vs. 24-21 % in controls) and increased sexual activity among the youngest participants (18-24 years; p-time < 0.0001, p-group = 0.96), all specific risk behaviors decreased over time similarly in both groups. The proportion of men reporting condom use at last sex increased for both groups, with a greater increase among circumcised men (30 vs. 6 %). We found no evidence of risk compensation in men following circumcision. Concerns about risk compensation should not impede the widespread scale-up of VMMC initiatives.

Abstract access 

Editor’s notes:  There has always been a concern that scale-up of voluntary medical male circumcision (VMMC) may be accompanied by risk compensation – i.e. an increase in risky behaviour in response to perceived risk reduction. To date, data on risk compensation following VMMC have been from the trial populations (including extended follow-up), and this is the first longitudinal study to assess risk compensation associated with MC in the context of a successful national scale-up in Kenya. The study is reassuring in that it showed no evidence of behavioural risk compensation over two years of follow-up. Further, the men exposed to the VMMC programme (both as circumcised clients and through informational messages as uncircumcised controls), meaningfully shifted towards safer sexual behaviours.  This suggests that, as long as VMMC programmes include emphasis on continuing risk reducing practices, there seems to be little risk compensation following scale-up of male circumcision.

Africa
Kenya
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Identifying people most likely to benefit from HIV pre-exposure prophylaxis

HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial.

Buchbinder SP, Glidden DV, Liu AY, McMahan V, Guanira JV, Mayer KH, Goicochea P, Grant RM. Lancet Infect Dis. 2014 Jun;14(6):468-75. doi: 10.1016/S1473-3099(14)70025-8. Epub 2014 Mar 7.

Background: For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections (population-attributable fraction [PAF]) and for whom the number needed to treat (NNT) to prevent infection is lowest. We aimed to estimate the PAF and NNT of participants in the iPrEx (Pre-Exposure Prophylaxis Initiative) trial.

Methods: The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in 2 499 men who have sex with men (MSM) and transgender women. Participants aged 18 years or older who were male at birth were enrolled from 11 trial sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants were randomly assigned (1:1) to receive either a pill with active pre-exposure prophylaxis or placebo, taken daily. We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model, and we calculated the PAF and NNT for risk behaviour subgroups..

Findings: Patients were enrolled between July 10, 2007, and Dec 17, 2009, and were followed up until Nov 21, 2010. Of the 2 499 MSM and transgender women in the iPrEx trial, 1 251 were assigned to pre-exposure prophylaxis and 1 248 to placebo. 83 of 1 248 patients in the placebo group became infected with HIV during follow-up. Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom (adjusted hazard ratio [AHR] 5.11, 95% CI 1.55-16.79). The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was 64% (prevalence 60%). Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus (PAF 53%, prevalence 54%, AHR 4.76, 95% CI 1.44-15.71); by contrast, the PAF for receptive anal intercourse without a condom with an HIV-positive partner was 1% (prevalence 1%, AHR 7.11, 95% CI 0.70-72.75). The overall NNT per year for the cohort was 62 (95% CI 44-147). NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom (NNT 36), cocaine use (12), or a sexually transmitted infection (41). Having one partner and insertive anal sex without a condom had the highest NNTs (100 and 77, respectively).

Interpretation: Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom, even if they perceive their partners to be HIV negative. Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis. Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women.

Abstract access 

Editor’s notes: Pre-exposure prophylaxis (PreP) is the only biomedical prevention activity shown to be effective against acquisition of HIV in men who have sex with men (MSM) and transgender women, in a randomised controlled trial. The US Centers for Disease Control (CDC) and WHO recommend PreP for MSM and transgender women at high risk of HIV infection. However, many health care providers have difficulty assessing risk and neither the CDC nor WHO has yet provided specific behavioural criteria for when to use pre-exposure prophylaxis. The purpose of this study was to identify subpopulations of participants within the iPrEx trial, for whom PreP may have the largest effect on HIV prevention. The findings suggest that MSM and transgender women can be screened for potential eligibility for PreP in clinical practice by asking about recent receptive anal intercourse without a condom. Substance use history and testing for sexually transmitted infections should also be considered, to inform individual decisions to start pre-exposure prophylaxis.

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Widow cleansing and inheritance practices amongst the Luo limit women’s options to use current HIV prevention methods

 

Widow cleansing and inheritance among the Luo in Kenya: the need for additional women-centred HIV prevention options.  

Perry B, Oluoch L, Agot K, Taylor J, Onyango J, Ouma L, Otieno C, Wong C, Corneli A J Int AIDS Soc. 2014; 17(1): 19010. Epub Jun 26, 2014.  doi:  10.7448/IAS.17.1.19010

Introduction: The customs of widow cleansing and widow inheritance are practiced in several communities throughout sub-Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a "cleanser," without the use of a condom, in order to remove the impurity ascribed to her after her husband's death. Luo couples, including widows, are also expected to engage in sex preceding specific agricultural activities, building homes, funerals, weddings, and other significant cultural and social events. Widows who are inherited for the purpose of fulfilling cultural obligation have a higher prevalence of HIV than those who remain un-inherited or are inherited for the purpose of companionship.

Methods: As part of a larger descriptive qualitative study to inform study procedures for FEM-PrEP, an HIV prevention pre-exposure prophylaxis clinical trial, we conducted 15 semi-structured interviews (SSIs) with widows, 15 SSIs with inheritors, and four focus group discussions with widows in the Bondo and Rarieda districts in Nyanza Province to explore the HIV risk context within widow cleansing and inheritance practices. Thematic qualitative analysis was used to analyze the data.

Results: The majority of widows reported in the demographic questionnaire being inherited, and most widows in the SSIs described participating in the cleansing ritual. We identified two main themes related to HIV prevention within the context of widow cleansing and inheritance: 1) widows must balance limiting their risk for HIV infection with meeting cultural expectations and ensuring that their livelihood needs are met, and 2) sexual abstinence undermines cultural expectations in widowhood while the use of condoms is deemed inappropriate in fulfilling culturally prescribed sexual rituals, and is often beyond the widow's ability to negotiate.

Conclusions: Women-controlled HIV prevention methods such as antiretroviral-based oral pre-exposure prophylaxis, vaginal gels, and vaginal rings are needed for HIV-negative widows who engage in sexual rituals related to widowhood.

Abstract  Full-text [free] access  

Editor’s notes: This paper provides an in-depth insight into the practice of widow cleansing and its implications for widows’ vulnerability to contracting HIV. The paper describes the practice of widow cleansing by the Luo in Kenya. This entails the requirement for widows to have sexual intercourse with a non-relative of her deceased husband to “cleanse” the impurity she has acquired from the death of her husband. Following this practice widows are “inherited”, traditionally by an in-law but more recently by a professional inheritor who inherits widows for money. Relationships with professional inheritors commonly entail sexual intercourse and financial and emotional support for the widow. These relationships can be ended if not fulfilled to expectation. Alongside this, there are other expectations for widows to perform sexual intercourse with other men as part of ceremonies.

To understand the sexual risk-taking behaviours of Luo widows and inheritors, in-depth interviews and focus groups were conducted with widows and inheritors. This was part of a larger qualitative study during the FEM-PrEP trial. The findings revealed that widows were aware of their risk of HIV infection through cleansing and inheritance practices, which often entailed sexual intercourse without a condom. However, women’s concerns about this were outweighed by the need to fulfil cultural expectations to avoid being ostracised, and importantly to receive financial support. Whilst some women were able to use condoms with inheritors, this only occurred in new relationships or during menstruation or pregnancy. Widows and inheritors reported that condoms were rarely used during “cleansing” practices as the mixing of semen and vaginal fluids is essential to remove impurities.

Whilst this study reveals similar constraints on condom use for women in long-term relationships it highlights the additional complexity for Luo widows in relation to cleansing and inheritance practices. These practices legitimise multiple concurrent relationships and sex without a condom. Importantly, as a strongly embedded practice this gives widows limited options to use condoms or abstinence to prevent HIV infection. The authors suggest that Luo widows would benefit from access to biomedical HIV prevention methods, including PrEP and microbicides.

Africa
Kenya
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Being a man, being circumcised, in northern Kenya

Attitudes, perceptions and potential uptake of male circumcision among older men in Turkana County, Kenya using qualitative methods.

Macintyre K, Andrinopoulos K, Moses N, Bornstein M, Ochieng A, Peacock E, Bertrand J. PLoS One. 2014 May 6;9(5):e83998. doi: 10.1371/journal.pone.0083998. eCollection 2014.

Background: In many communities, older men (i.e., over 25 years of age) have not come forward for Voluntary Medical Male Circumcision (VMMC) services. Reasons for low demand among this group of men are not well understood, and may vary across geographic and cultural contexts. This paper examines the facilitators and barriers to VMMC demand in Turkana County, Kenya, with a focus on older men. This is one of the regions targeted by the VMMC program in Kenya because the Turkana ethnic group does not traditionally circumcise, and the rates of HIV and STD transmission are high.

Methods and findings: Twenty focus group discussions and 69 in-depth interviews were conducted with circumcised and uncircumcised men and their partners to elicit their attitudes and perceptions toward male circumcision. The interviews were conducted in urban, peri-urban, and rural communities across Turkana. Our results show that barriers to circumcision include stigma associated with VMMC, the perception of low risk for HIV for older men and their "protection by marriage," cultural norms, and a lack of health infrastructure. Facilitators include stigma against not being circumcised (since circumcision is associated with modernity), protection against disease including HIV, and cleanliness. It was also noted that older men should adopt the practice to serve as role models to younger men.

Conclusions: Both men and women were generally supportive of VMMC, but overcoming barriers with appropriate communication messages and high quality services will be challenging. The justification of circumcision being a biomedical procedure for protection against HIV will be the most important message for any communication strategy.

 Abstract  Full-text [free] access 

Editor’s notes:  Queues of young men and boys awaiting medical male circumcision have become a common sight at health centres, during circumcision campaigns in many parts of Africa. The authors of this paper examine why older men, defined as men over 25 years, among the Turkana of northern Kenya, have been reluctant to be circumcised. They highlight the very important role of culture – the Turkana do not have a tradition of circumcision. Neighbouring groups do circumcise, so not being circumcised is a part of being different, of embracing Turkana male identity. In addition, not being circumcised was associated with faithfulness in marriage. If a man is married then there should be no need for protection from infection, since he should not be having sex outside his marriage. However, as other studies have found, concerns about the spread of HIV as well as a desire to be seen as clean and as a role model for younger men, were facilitators of circumcision. As the authors note, appropriate communication messages are important to promote circumcision among older men. But so is an awareness of, and sensitivity to, cultural and masculine identity.

Africa
Kenya
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Scale-up of voluntary medical male circumcision: context matters

Voluntary medical male circumcision (VMMC) in Tanzania and Zimbabwe: service delivery intensity and modality and their influence on the age of clients.

Ashengo TA, Hatzold K, Mahler H, Rock A, Kanagat N, Magalona S, Curran K, Christensen A, Castor D, Mugurungi O, Dhlamini R, Xaba S, Njeuhmeli E. PLoS One. 2014 May 6;9(5):e83642. doi: 10.1371/journal.pone.0083642. eCollection 2014.

Background: Scaling up voluntary medical male circumcision (VMMC) to 80% of men aged 15-49 within five years could avert 3.4 million new HIV infections in Eastern and Southern Africa by 2025. Since 2009, Tanzania and Zimbabwe have rapidly expanded VMMC services through different delivery (fixed, outreach or mobile) and intensity (routine services, campaign) models. This review describes the modality and intensity of VMMC services and its influence on the number and age of clients.

Methods and findings: Program reviews were conducted using data from implementing partners in Tanzania (MCHIP) and Zimbabwe (PSI). Key informant interviews (N = 13 Tanzania; N = 8 Zimbabwe) were conducted; transcripts were analyzed using Nvivo. Routine VMMC service data for May 2009-December 2012 were analyzed and presented in frequency tables. A descriptive analysis and association was performed using the z-ratio for the significance of the difference. Key informants in both Tanzania and Zimbabwe believe VMMC scale-up can be achieved by using a mix of service delivery modality and intensity approaches. In Tanzania, the majority of clients served during campaigns (59%) were aged 10-14 years while the majority during routine service delivery (64%) were above 15 (p<0.0001). In Zimbabwe, significantly more VMMCs were done during campaigns (64%) than during routine service delivery (36%) (p<0.00001); the difference in the age of clients accessing services in campaign versus non-campaign settings was significant for age groups 10-24 (p<0.05), but not for older groups.

Conclusions: In Tanzania and Zimbabwe, service delivery modalities and intensities affect client profiles in conjunction with other contextual factors such as implementing campaigns during school holidays in Zimbabwe and cultural preference for circumcision at a young age in Tanzania. Formative research needs to be an integral part of VMMC programs to guide the design of service delivery modalities in the face of, or lack of, strong social norms.

Abstract  Full-text [free] access 

Editor’s notes: To reach the target of 80% coverage within five years, an estimated 20.3 million voluntary medical male circumcision (VMMC) procedures among men aged 15-49 years need to be performed in eastern and southern Africa. Approximately 6 million VMMCs have been conducted by the end of 2013.  Rapid scale-up is needed, and this paper provides insights into different service delivery strategies for the scale-up. It emphasises the importance of the cultural context in shaping the uptake of VMMC. Delivery modalities include routine service delivery at existing health care facilities and campaign service delivery. Campaigns have high throughput for short periods of time, and may be conducted at a variety of sites. These include mobile sites (temporary structures) and outreach sites (structures temporarily modified for VMMC service provision). The study highlights the need for VMMC programmes to take into account the underlying social context. For example, in Tanzania, there is an underlying cultural perception that male circumcision is most appropriate before or during puberty. This is reflected in the young age of the clients, particularly during campaigns, where boys may be more susceptible to peer pressure. In Zimbabwe, circumcision was not traditionally practised, so uptake of VMMC is more strongly linked with the convenience of service provision. 

Africa
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High levels of acceptability and safety profile of a disposable device for adult voluntary medical male circumcision

Randomized controlled trial of the Shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.

Sokal DC, Li PS, Zulu R, Awori QD, Combes SL, Simba RO, Lee R, Hart C, Perchal P, Hawry HJ, Bowa K, Goldstein M, Barone MA. J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):447-55. doi: 10.1097/QAI.0000000000000061.

Objective: To compare clinical profiles of Shang Ring versus conventional circumcisions.

Design: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites.

Methods: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups.

Results: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 +/- 1.9 vs. 2.3 +/- 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring.

Conclusions: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

Abstract access 

Editor’s notes: Rapid scale up of voluntary medical male circumcision (VMMC) is needed to impact on the HIV epidemic. The current goal is for 20 million VMMCs to be conducted in countries with generalised HIV epidemics by 2016. To achieve this, it is essential to examine alternative methods to conventional surgery. The Shang Ring is one such method, which is a disposable, single-use, minimally invasive device that has been widely used in China and is starting to be used in sub-Saharan Africa. This is one of the first larger scale randomised control trial comparing an adult VMMC device with conventional surgery. The results show very high levels of acceptability of the Shang Ring among both participants and providers, and a reassuring safety profile showing a similar risk of adverse events using the two methods.  However, the risk of a moderate/severe adverse event was higher in this study than in a previous trial of the Shang Ring in Uganda. This finding underscores that back-up services are needed in case of complications.

Africa
Kenya, Zambia
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Importance of promoting condom use to young people before sexual debut

Putting the C back into the ABCs: a multi-year, multi-region investigation of condom use by Ugandan youths 2003-2010.

Valadez JJ, Jeffery C, Davis R, Ouma J, Lwanga SK, Moxon S. PLoS One. 2014 Apr 4;9(4):e93083. doi: 10.1371/journal.pone.0093083. eCollection 2014.

A major strategy for preventing transmission of HIV and other STIs is the consistent use of condoms during sexual intercourse. Condom use among youths is particularly important to reduce the number of new cases and the national prevalence. Condom use has been often promoted by the Uganda National AIDS Commission. Although a number of studies have established an association between condom use at one's sexual debut and future condom use, few studies have explored this association over time, and whether the results are generalizable across multiple locations. This multi time point, multi district study assesses the relationship between sexual debut and condom use and consistent use of condoms thereafter. Uganda has used Lot Quality Assurance Sampling surveys since 2003 to monitor district level HIV programs and improve access to HIV health services. This study includes 4 518 sexually active youths interviewed at five time points (2003-2010) in up to 23 districts located across Uganda. Using logistic regression, we measured the association of condom use at first sexual intercourse on recent condom usage, controlling for several factors including: age, sex, education, marital status, age at first intercourse, geographical location, and survey year. The odds of condom use at last intercourse, using a condom at last intercourse with a non-regular partner, and consistently using a condom are, respectively, 9.63 (95%WaldCI = 8.03-11.56), 3.48 (95%WaldCI = 2.27-5.33), and 11.12 (95%WaldCI = 8.95-13.81) times more likely for those individuals using condoms during their sexual debut. These values did not decrease by more than 20% when controlling for potential confounders. The results suggest that HIV prevention programs should encourage condom use among youth during sexual debut. Success with this outcome may have a lasting influence on preventing HIV and other STIs later in life.

Abstract  Full-text [free] access 

Editor’s notes: When used consistently and correctly, condom use is highly effective for prevention of HIV and other sexually transmitted infections. The low rates of condom use in many settings have been a persistent concern since the early days of the HIV epidemic. This study looks at reported condom use in a large dataset of Ugandan youth aged 15-24 years, over a seven year period (2003-2010), sampled to be nationally representative.  Of the 4 518 sexually active youth included in the surveys, half reported never having used a condom. The key finding of the paper is that reported condom use at sexual debut is very strongly associated with condom use at most recent intercourse, and with consistent condom use with both regular and importantly, with higher-risk non-regular partners. The association persisted after adjustment for likely confounders related to sexual behaviour, such as education and marital status. There are inherent difficulties with achieving high levels of consistent condom use among youth, including socio-economic factors that make negotiating condom use difficult. But this paper highlights the importance of encouraging youth to use condoms at first sex. The results suggest that establishing patterns of behaviour at this early stage may help promote and reinforce ongoing safe sex practices.  This, along with messages about delaying the age of sexual debut, promoting safe sex behaviour, and voluntary medical male circumcision can all help in the prevention of HIV and other STIs.

Africa
Uganda
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Shorter duration of seroprotection following vaccination in people living with HIV

Long-term immune responses to vaccination in HIV-infected patients: a systematic review and meta-analysis.  

Kerneis S, Launay O, Turbelin C, Batteux F, Hanslik T, Boelle P. Clin Infect Dis. 2014 Apr;58(8):1130-9. doi: 10.1093/cid/cit937. Epub 2014 Jan 10.

Vaccine-induced antibodies may wane more quickly in persons living with human immunodeficiency virus (HIV) than in healthy individuals. We reviewed the literature on vaccines routinely recommended in HIV-infected patients to estimate how seroprotection decreases over time in those who initially responded to immunization. For each study retrieved from the literature, the decrease of seroprotection was modeled with a log binomial generalized linear model, and data were pooled in a meta-analysis to provide estimates of seroprotection 2 and 5 years after the last vaccine administration. Our analyses confirmed that the duration of seroprotection was shorter in HIV-infected patients and that with current guidelines, a substantial proportion of patients would have lost protective antibodies before a booster was proposed. We therefore discuss the implications for the monitoring of antibody levels and timing of revaccination in these patients.

 Abstract access 

Editor’s notes: People living with HIV are recognised to have suboptimal immune responses to vaccination. In particular little is known about the long-term persistence of protection following a primary immune response. This systematic review included original experimental and observational studies of licensed vaccines in people living with HIV which were published prior to January 2012. Studies were eligible for inclusion if participants had a primary response to vaccination and antibody titres measured six months or more following the last dose. Meta-analyses were conducted where there were ≥2 prospective studies available (hepatitis B, hepatitis A, measles, tetanus). The analyses confirmed that the duration of seroprotection was shorter in people living with HIV than the general population. For example, some 61% of children and less than half of adult primary responders maintained seroprotection two years after hepatitis B vaccination and only 17% by five years for both children and adults. In contrast persistence of antibody response to hepatitis A was far higher (92% after two years and 82% after five years). Immune status and antiretroviral therapy appeared to play a role in persistence of immune response. However there was no evidence to suggest that double dosing or increasing the number of doses prolonged the period of protection. The authors discuss the limitations of the published studies and discuss the implications of their findings in terms of monitoring of antibody response and timing of revaccinations. 

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Improving antiretroviral therapy adherence among people who inject drugs

Methadone maintenance therapy decreases the rate of antiretroviral therapy discontinuation among HIV-positive illicit drug users.

Reddon H, Milloy MJ, Simo A, Montaner J, Wood E, Kerr T. AIDS Behav. 2014 Apr;18(4):740-6. doi: 10.1007/s10461-013-0584-z.

We sought to examine whether methadone maintenance therapy (MMT) decreased rates of antiretroviral therapy (ART) discontinuation and was associated with plasma HIV RNA responses among a cohort of illicit drug users. Cumulative ART discontinuation rates were estimated using Kaplan-Meier methods and factors independently associated with ART discontinuation were identified using Cox proportional hazards regression. Engagement in MMT was negatively and independently associated with ART discontinuation [Adjusted Relative Hazard = 0.67 (95 % CI 0.54-0.83); p < 0.001]. Among participants receiving ART and MMT, 81.6 % of plasma HIV-1 RNA assessments were <500 copies/mL, while 65.81 % of HIV-1 RNA assessments among those prescribed ART without MMT were <500 copies/mL (p < 0.001). These results demonstrate that engagement in MMT conferred a protective benefit against ART discontinuation and was associated with a significant increase in plasma HIV RNA suppression among HIV-infected opioid-dependent drug users.

Abstract access 

Editor’s notes: This study examined the effect of methadone maintenance therapy (MMT) on rates of discontinuation of antiretroviral therapy (ART) among people who inject drugs (PWID) in Vancouver, Canada. Data are taken from an established cohort of PWID followed up between 1996 and 2008. Cox regression models are used to account for multiple observations among individuals to allow for discontinuation and restarting MMT across the study period increasing the sample size. Key confounders associated with both use of MMT and adherence to ART are adjusted for, including sex, age, homelessness, frequency of injection, cocaine use and sex work. One limitation of this study is the fairly simplified definition of MMT used, which was defined as any self-report of MMT treatment in the last six months which ranged from a single dose to 100% adherence. MMT is taken orally and is supervised. However, there was no information on the range of uptake of MMT is given, what proportion were 100% adherent and what proportion had a single dose. The findings demonstrate that any contact with the MMT programme has a positive association with the continuation of ART and increased HIV RNA suppression. This is an important finding since previous research has demonstrated that reducing community levels of viral load among populations of PWID is associated with decreased incidence of HIV irrespective of injecting and sexual risk behaviours. This paper usefully contributes to the discussions on the best way to deliver ART to PWID. It supports previous research that has demonstrated the role of MMT and combination approaches in preventing and treating HIV. Given the lack of MMT in some countries where HIV is high among PWID, this is important. A systematic review to assess the effect of methadone on ARV adherence is needed to examine this question further. 

Northern America
Canada
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Intimate partner violence common among microbicide trial participants

Hidden harms: women's narratives of intimate partner violence in a microbicide trial, South Africa.

Stadler J, Delany-Moretlwe S, Palanee T, Rees H. Soc Sci Med. 2014 Jun;110:49-55. doi: 10.1016/j.socscimed.2014.03.021. Epub 2014 Mar 22.

In a context of high rates of intimate partner violence (IPV), trials of female-controlled technologies for HIV prevention such as microbicides may increase the possibility of social harms. Seeking to explore the relationship between IPV and microbicide use further, this paper documents women’s narratives of participating in the Microbicide Development Program (MDP) trial in Johannesburg, South Africa, and experiences of partner violence and conflict. A social science sub-study, nested within the trial, was conducted between September 2005 and August 2009, and 401 serial in-depth-interviews were undertaken with 150 women. Using coded interview transcripts, we describe the distribution of IPV and the possible association thereof with microbicide gel use and trial participation. More than a third of these 150 women reported IPV, of which half the cases were related to involvement in the trial. In their narratives, those women reporting IPV cast their partners as authoritarian, controlling and suspicious and reported verbal abuse, abandonment, and in some cases, beatings. Shared experiences of everyday violence shaped women’s feelings of unease about revealing their participation in the trial to intimate partners and attempted concealment further contributed to strains and conflict within relationships. Our findings point to the role of social scientific enquiry in identifying the less obvious, hidden negative impacts of participation in a clinical trial therefore exposing limitations in the biomedical construction of ‘social harms’, as well as the implications thereof for potential future use outside the clinical trial setting.

Abstract access 

Editor’s notes: Violence within intimate partnerships is common globally. Longitudinal research from South Africa and Uganda has shown that women in violent relationships are at increased risk of acquiring HIV infection. This study presents qualitative data, collected as part of a nested study of 150 women in Orange Farm, South Africa who participated in the Microbicide Development Programme (MDP) trial. Although experiences of violence were not framed as a social harm in the trial, or actively explored in the research, violence did emerge as an important issue. More than a third of respondents were living with men who were physically or psychologically violent and/or controlling. The violent events resulting from trial participation were primarily psychological, along with some incidents of physical violence.

Women described using a range of strategies to try to minimise the risk of violence that could result from being part of the trial. Some women were very adept at negotiating gel use with a controlling, violent or potentially violent partner.  The pervasiveness of violence and its links with HIV vulnerability illustrates the challenges of reducing women's risk of HIV acquisition. The findings suggests that female initiated technologies, such as microbicides, are urgently needed, but that broader programmes, to address violence within relationships, will also be important. The findings also raise issues of how to conceptualise and respond to such forms of social harms within clinical trials. The findings suggest that trialists need to be better equipped to deal with IPV, for example by providing counselling and social and legal referral, as well as possibly supporting the sharing of successful strategies between women. It also highlights the potential synergies that could be obtained by more effectively bringing together biomedical developments, such as microbicides, along with broader development initiatives, that seek to prevent violence within relationships. 

Africa
South Africa
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