Articles tagged as "Sexual transmission and prevention"

HIV Self-testing acceptable to vocational students in South Africa

High acceptability of HIV self-testing among technical vocational education and training college students in Gauteng and North West province: what are the implications for the scale up in South Africa?

Mokgatle MM, Madiba S. PLoS One. 2017 Jan 31;12(1):e0169765. doi: 10.1371/journal.pone.0169765. eCollection 2017.

Background: Although HIV self-testing (HIVST) is globally accepted as an important complement to existing HIV testing approaches, South Africa has lagged behind in its adoption. As a result, data on the acceptability and uptake of HIVST is limited. The study investigated the acceptability of HIVST among students in Technical Vocational Education and Training (TVET) colleges in two provinces in South Africa.

Methods: A cross-sectional survey using a self-administered structured questionnaire was used to collect data among 3662 students recruited from 13 TVET colleges.

Results: The mean age of the students was 21.9 years. The majority (80.9%) were sexually active; while 66.1% reported that they had one sexual partner, and 33.9% had two or more sexual partners in the past year, and 66.5% used condoms during the last sexual act. Three-quarters tested for HIV in the past year but less than half knew about HIVST prior to the survey. The acceptability of HIVST was high; about three-quarters showed a willingness to purchase a self-test kit and a majority would self-test with partners. Acceptability of HIVST was associated with being sexually active (OR = 1.73, p = 0.02, confidence interval (CI): 1.08-2.75), having ever been tested for HIV (OR = 1.74, p = 0.001, CI: 1.26-2.38), and having multiple sexual partners (OR = 0.61, p = 0.01, CI: 0.42-0.88). Three-quarters would confirm test results at a local health facility. In terms of counselling, telephone hotlines were acceptable to only 39.9%, and less than half felt that test-kit leaflets would provide sufficient information to self-test.

Interpretations: The high acceptability of HIVST among the students calls for extensive planning and preparation for the scaling up of HIVST in South Africa. In addition, campaigns similar to those conducted to promote HIV counselling and testing (HCT) should be considered to educate communities about HIVST.

Abstract  Full-text [free] access  

Editor’s notes: The percentage of people living with HIV who know their status (the first 90 of the UNAIDS 90:90:90 treatment target) has been consistently well below the stated target in national HIV treatment cascades. HIV self-testing is an exciting strategy being used to increase the uptake of testing, and has recently been adopted in South Africa. This study had two aims; firstly to assess the participants attitudes to currently available HIV counselling and testing services and secondly to assess the level of acceptability of HIV self-testing. The study population were students in technical and vocational education and training colleges in South Africa.

Among people who had not tested for HIV in the past year, reasons given for non-uptake of testing (other than a low perception of risk) included a fear of stigma associated with a positive test or a lack of comfort with testing in a hospital setting. Less than half of participants had heard of HIV self-testing, but when the concept was explained to them, around 80% expressed a willingness to use it if it was available, and 70% were willing to purchase the self-test kit. These results are consistent with other studies of HIV self-testing uptake and acceptability in sub-Saharan Africa.

The stated willingness of participants to present at a clinic for a confirmatory test is encouraging. However, this may not reflect actual behaviour, especially in a setting where there is currently no plan or system to link people with positive HIV self-test results to a clinic for confirmatory testing. However, the drive to improve counselling and linkage around self-testing needs to be balanced against the fundamental principle for HIV self-testing to allow choice for users to test without the need for a health worker to be present, and the privacy associated with this. Further work may include assessing acceptability of using remote services to complement HIV self-testing such as telephone hotlines or other counselling strategies. 

Africa
South Africa
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Mixed methods in biomedical intervention trials yield rich data – the VOICE-D qualitative study

How presentation of drug detection results changed reports of product adherence in South Africa, Uganda and Zimbabwe.

Musara P, Montgomery ET, Mgodi NM, Woeber K, Akello CA, Hartmann M, Cheng H, Levy L, Katz A, Grossman CI, Chirenje ZM, van der Straten A, Mensch B. AIDS Behav. 2017 Jan 21. doi: 10.1007/s10461-017-1685-x. [Epub ahead of print]

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.

Abstract access  

Editor’s notes: The VOICE trial looked at the effectiveness of PrEP and vaginal microbicides in women in three African countries. One of the findings of the study was low product adherence among some women, based on retrospective drug level testing. In this paper, the authors compare data on product adherence from before and after participants were given plasma drug detection results. The findings are revealing, not least because many of women interviewed explained why they had claimed to be adhering to the drug, when they were not. Women gave many reasons for not being open about taking their medicines/use of the microbicide. It is interesting that a few women continued to say that they were good adherers, even when presented with drug plasma data, which suggested otherwise. This, the authors note, requires further investigation. 

The findings provide valuable evidence of the shortcomings of collecting self-reported adherence data. The use of biomedical markers to reveal drug plasma levels is important. However, the qualitative research, which documented the discussion around those findings, is both fascinating and extremely useful. Perhaps in future there will be an even greater willingness to fund good qualitative research as a key component of trials?

Africa
South Africa, Uganda, Zimbabwe
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Getting to 80% male circumcision

Obtaining a male circumcision prevalence rate of 80% among adults in a short time: An observational prospective intervention study in the Orange Farm township of South Africa.

Marshall E, Rain-Taljaard R, Tsepe M, Monkwe C, Taljaard D, Hlatswayo F, Xaba D, Molomo T, Lissouba P, Puren A, Auvert B. Medicine (Baltimore). 2017 Jan;96(4):e5328. doi: 10.1097/MD.0000000000005328.

World Health Organization recommends a target for the male circumcision prevalence rate of 80%. This rate will have a substantial impact on the human immunodeficiency virus-acquired immunodeficiency syndrome epidemic in Eastern and Southern Africa. The objective of the study was to assess whether an innovative intervention can lead to an increased voluntary male medical circumcision (VMMC) uptake among adults in a short time. This prospective observational study of a demand generation intervention was conducted in the township of Orange Farm (South Africa) in August to November 2015. In this community male circumcision prevalence rate among adults was stable between 2010 and 2015 at 55% and 57%, despite regular VMMC campaigns at community level and the presence of a VMMC clinic that offered free VMMC. The intervention took place in a random sample of 981 households where 522 men aged 18 to 49 years accepted to participate in the study. Among the 226 uncircumcised men, 212 accepted to be enrolled in the intervention study. A personal male circumcision adviser trained in interpersonal communication skills was assigned to each uncircumcised participant. The male circumcision advisers were trained to explain the risks and benefits of VMMC, and to discuss 24 possible reasons given by men for not being circumcised. Participants were then followed for 9 weeks. Each participant had a maximum of 3 motivational interviews at home. Participants who decided to be circumcised received financial compensation for their time equivalent to 2.5 days of work at the minimum South African salary rate. Among the 212 uncircumcised men enrolled in the intervention, 69.8% (148/212; 95% confidence interval [CI]; 63.4%-75.7%) agreed to be circumcised, which defines the uptake of the intervention. The male circumcision prevalence rate of the sample increased from 56.7% (296/522) to 81.4% (425/522; 77.9%-84.6%), P < 0.001, corresponding to a relative increase of 43.6% (95% CI: 35.4%-53.7%). The reported reasons for accepting circumcision were motivational interviews with the male circumcision adviser (83.1%), and time compensation (39.4%). Increased uptake of VMMC uptake can be obtained in a short time among adult males but requires an intense intervention centered on uncircumcised men at an individual level and time compensation.

Abstract  Full-text [free] access

Editor’s notes: As there are diverse motives for and barriers to voluntary male medical circumcision (VMMC), a range of programmes are required to reach WHO’s target of 80% male circumcision. This demand-creation activity study took place in a setting where, following school talks, street animation, flyers and local radio advertising, circumcision prevalence had risen to 57% by 2010 but had then plateaued. The programme was based on the theory that saturation had not been reached and many men who remained uncircumcised were not opposed to it but needed the right opportunity and circumstances to motivate them. In just over two months the prevalence of adult male circumcision in the study sample increased to over 80%, (WHO goal) as a result of implementing up to three home-based motivational interviews, plus time compensation of half a week’s pay at minimum wage for men who had VMMC.

Uptake was highest among the oldest men (aged 40-49 years), who had the lowest prevalence of circumcision before the study. Possibly previous programmes that were primarily focussed on adolescents were less likely to affect them. The highest rates were achieved in the youngest age group (aged 18-24 years), who were the most likely to already be circumcised before the study. Time to think about their options at home was important to participants. Most men who opted for VMMC said it was very important to have discussed the situation with their partner (80%) and with relatives or friends (78%). The three motivational interviews produced diminishing yield; 112/212 men sought VMMC after the first interview, 28/78 after the second and 8/54 after the third. After one interview plus financial compensation, the male circumcision prevalence in the sample increased to 75%.

The study is an example of a locally developed and setting-appropriate activity, quickly and rigorously tested in a realistic setting. In this manner, research questions can be relevant to the context and the results can be put into practice. 

Africa
South Africa
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Benefits of including males living with HIV in voluntary medical male circumcision - modelling analysis

Could circumcision of HIV-positive males benefit voluntary medical male circumcision programs in Africa? Mathematical modeling analysis.

Awad SF, Sgaier SK, Lau FK, Mohamoud YA, Tambatamba BC, Kripke KE, Thomas AG, Bock N, Reed JB, Njeuhmeli E, Abu-Raddad LJ. PLoS One. 2017 Jan 24;12(1):e0170641. doi: 10.1371/journal.pone.0170641. eCollection 2017.

Background: The epidemiological and programmatic implications of inclusivity of HIV-positive males in voluntary medical male circumcision (VMMC) programs are uncertain. We modeled these implications using Zambia as an illustrative example.

Methods and findings: We used the Age-Structured Mathematical (ASM) model to evaluate, over an intermediate horizon (2010-2025), the effectiveness (number of VMMCs needed to avert one HIV infection) of VMMC scale-up scenarios with varying proportions of HIV-positive males. The model was calibrated by fitting to HIV prevalence time trend data from 1990 to 2014. We assumed that inclusivity of HIV positive males may benefit VMMC programs by increasing VMMC uptake among higher risk males, or by circumcision reducing HIV male-to-female transmission risk. All analyses were generated assuming no further antiretroviral therapy (ART) scale-up. The number of VMMCs needed to avert one HIV infection was projected to increase from 12.2 VMMCs per HIV infection averted, in a program that circumcises only HIV-negative males, to 14.0, in a program that includes HIV-positive males. The proportion of HIV-positive males was based on their representation in the population (e.g. 12.6% of those circumcised in 2010 would be HIV-positive based on HIV prevalence among males of 12.6% in 2010). However, if a program that only reaches out to HIV-negative males is associated with 20% lower uptake among higher-risk males, the effectiveness would be 13.2 VMMCs per infection averted. If improved inclusivity of HIV-positive males is associated with 20% higher uptake among higher-risk males, the effectiveness would be 12.4. As the assumed VMMC efficacy against male-to-female HIV transmission was increased from 0% to 20% and 46%, the effectiveness of circumcising regardless of HIV status improved from 14.0 to 11.5 and 9.1, respectively. The reduction in the HIV incidence rate among females increased accordingly, from 24.7% to 34.8% and 50.4%, respectively.

Conclusion: Improving inclusivity of males in VMMC programs regardless of HIV status increases VMMC effectiveness, if there is moderate increase in VMMC uptake among higher-risk males and/or if there is moderate efficacy for VMMC against male-to-female transmission. In these circumstances, VMMC programs can reduce the HIV incidence rate in males by nearly as much as expected by some ART programs, and additionally, females can benefit from the intervention nearly as much as males.

Abstract  Full-text [free] access

Editor’s notes: Evidence from randomised control trials and modelling studies suggest that voluntary male medical circumcision (VMMC) is a cost-effective HIV prevention programme. A deterministic compartmental age structured HIV model was used to assess benefits of including HIV positive males in VMMC programmes. The HIV model was parameterized using HIV biological and behavioural data for sub-Saharan Africa.  The model was fit to HIV prevalence for Zambia in the years between 1990 and 2014. The model used baseline circumcision coverages from Zambia Demographic and Health Survey 2007. The authors analysed the model for three VMMC programme scenarios; circumcising HIV negative males only, circumcising both HIV negative and HIV positive males, and circumcising males regardless of their HIV status. Sensitivity analysis was conducted to ascertain the robustness of key model assumptions on the study findings. The findings from the study suggest that, improving the inclusivity of all males is likely to improve the effectiveness of VMMC programmes.  This will be the case if there is moderate increase in uptake among higher-risk males and/or moderate VMMC efficacy in preventing male-to-female transmission. This is a very interesting modelling study which gives insights to policymakers on factors to consider in designing VMMC programmes. 

Africa
Zambia
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Tell it like it is: risky sex after 40

Sexual behaviors and HIV status: a population-based study among older adults in rural South Africa.

Rosenberg MS, Gomez-Olive FX, Rohr JK, Houle BC, Kabudula CW, Wagner RG, Salomon JA, Kahn K, Berkman LF, Tollman SM, Barnighausen T. J Acquir Immune Defic Syndr. 2017 Jan 1;74(1):e9-e17.

Objective: To identify the unmet needs for HIV prevention among older adults in rural South Africa.

Methods: We analyzed data from a population-based sample of 5059 men and women aged 40 years and older from the study Health and Aging in Africa: Longitudinal Studies of INDEPTH Communities (HAALSI), which was carried out in the Agincourt health and sociodemographic surveillance system in the Mpumalanga province of South Africa. We estimated the prevalence of HIV (laboratory-confirmed and self-reported) and key sexual behaviors by age and sex. We compared sexual behavior profiles across HIV status categories with and without age-sex standardization.

Results: HIV prevalence was very high among HAALSI participants (23%, 95% confidence interval [CI]: 21 to 24), with no sex differences. Recent sexual activity was common (56%, 95% CI: 55 to 58) across all HIV status categories. Condom use was low among HIV-negative adults (15%, 95% CI: 14 to 17), higher among HIV-positive adults who were unaware of their HIV status (27%, 95% CI: 22 to 33), and dramatically higher among HIV-positive adults who were aware of their status (75%, 95% CI: 70 to 80). Casual sex and multiple partnerships were reported at moderate levels, with slightly higher estimates among HIV-positive compared to HIV-negative adults. Differences by HIV status remained after age-sex standardization.

Conclusions: Older HIV-positive adults in an HIV hyperendemic community of rural South Africa report sexual behaviors consistent with high HIV transmission risk. Older HIV-negative adults report sexual behaviors consistent with high HIV acquisition risk. Prevention initiatives tailored to the particular prevention needs of older adults are urgently needed to reduce HIV risk in this and similar communities in sub-Saharan Africa.

Abstract  Full-text [free] access 

Editor’s notes: This large population-based survey was designed to collect data on well-being, health status, cognitive functioning, and aspects of ageing among men and women 40 years of age or older (40+) in Mpumalanga, South Africa. The survey documented an unexpectedly high HIV prevalence of 23% in this age group. In the 50+ age group, almost one in five people (20%) was HIV-positive. This compares to an overall South African national estimate for adults 50 and over in 2012 of 7.6%, the Africa Centre KwaZulu-Natal estimate of 9.5%, and the previous Agincourt estimate of 16.5% in 2010-11. One explanation is that HIV prevalence among older South Africans is climbing as more people access life-prolonging antiretroviral treatment. In addition to this, each year people with HIV are ageing into the older age group. This study focused on the 40+ age group because life expectancy in the Agincourt study area had been low and collected sexual behaviour information for the previous two-year period, rather than the usual time period of 12 months. Nonetheless, the data obtained through computer-assisted personal interviews reveal ‘recent’ sexual behaviour that both challenges stereotypes that older people are not sexually active and suggests significant risk of HIV transmission and HIV acquisition. Two-thirds reported more than one lifetime sexual partner and although sexual activity did tend to decrease with age, 52% of men and 6% of women age 80 years and older had been sexually active in the previous two years. Only about half of people found to be HIV-positive knew their status (12%). This group of people living with HIV were far more likely to use condoms. This suggests that an offer of HIV testing in ways that can reach older people would assist in avoiding transmission to partners and in accessing antiretroviral therapy. Only one in seven sexually active HIV-negative people 40+ are using condoms in this setting. This highlights the urgent need for awareness raising to foster new sexual norms to avoid HIV acquisition by practising safer sex. It is time to get our heads out of the sand, recognise the sexuality of older people, and work with them to tailor specific HIV strategies to reduce HIV transmission and acquisition – they too are key to ending AIDS. 

Africa
South Africa
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Assisted partner services a safe, effective strategy to identify undiagnosed HIV cases in sub-Saharan Africa

Assisted partner services for HIV in Kenya: a cluster randomised controlled trial.

Cherutich P, Golden MR, Wamuti B, Richardson BA, Asbjornsdottir KH, Otieno FA, Ng'ang'a A, Mutiti PM, Macharia P, Sambai B, Dunbar M, Bukusi D, Farquhar C. Lancet HIV. 2016 Nov 29. pii: S2352-3018(16)30214-4. doi: 10.1016/S2352-3018(16)30214-4. [Epub ahead of print]

Background: Assisted partner services for index patients with HIV infections involves elicitation of information about sex partners and contacting them to ensure that they test for HIV and link to care. Assisted partner services are not widely available in Africa. We aimed to establish whether or not assisted partner services increase HIV testing, diagnoses, and linkage to care among sex partners of people with HIV infections in Kenya.

Methods: In this cluster randomised controlled trial, we recruited non-pregnant adults aged at least 18 years with newly or recently diagnosed HIV without a recent history of intimate partner violence who had not yet or had only recently linked to HIV care from 18 HIV testing services clinics in Kenya. Consenting sites in Kenya were randomly assigned (1:1) by the study statistician (restricted randomisation; balanced distribution in terms of county and proximity to a city) to immediate versus delayed assisted partner services. Primary outcomes were the number of partners tested for HIV, the number who tested HIV positive, and the number enrolled in HIV care, in those who were interviewed at 6 week follow-up. Participants within each cluster were masked to treatment allocation because participants within each cluster received the same intervention. This trial is registered with ClinicalTrials.gov, number NCT01616420.

Findings: Between Aug 12, 2013, and Aug 31, 2015, we randomly allocated 18 clusters to immediate and delayed HIV assisted partner services (nine in each group), enrolling 1305 participants: 625 (48%) in the immediate group and 680 (52%) in the delayed group. 6 weeks after enrolment of index patients, 392 (67%) of 586 partners had tested for HIV in the immediate group and 85 (13%) of 680 had tested in the delayed group (incidence rate ratio 4.8, 95% CI 3.7-6.4). 136 (23%) partners had new HIV diagnoses in the immediate group compared with 28 (4%) in the delayed group (5.0, 3.2-7.9) and 88 (15%) versus 19 (3%) were newly enrolled in care (4.4, 2.6-7.4). Assisted partner services did not increase intimate partner violence (one intimate partner violence event related to partner notification or study procedures occurred in each group).

Interpretation: Assisted partner services are safe and increase HIV testing and case-finding; implementation at the population level could enhance linkage to care and antiretroviral therapy initiation and substantially decrease HIV transmission.

Abstract access  

Editor’s notes: One of the greatest challenges to achieving goals such as the UNAIDS 90:90:90 treatment target is the development of more effective strategies to enable people undiagnosed living with HIV to be tested and engaged with care. One strategy for achieving this in high-income settings, albeit with a very limited evidence base, is assisted partner services. In this approach, health-care workers identify and attempt to contact the sexual partners of people recently diagnosed with HIV. These partners are then encouraged to be tested and engaged with care. This pragmatic cluster randomised study, conducted in Kenya, aimed to assess whether assisted partner services were feasible in a sub-Saharan African setting and if so, to measure the effectiveness in terms of additional individuals testing for HIV, receiving new HIV diagnoses and engaging with care as a result of the programme.

The results were striking, in that six weeks after enrolment almost five times as many partners of index cases in the immediate group (partners contacted  at enrolment) had been tested for HIV compared to the delayed group (partners contacted  six weeks after enrolment). There were five times as many new HIV diagnoses in the immediate group compared to the delayed group. There were also four times as many partners newly engaged with care in the immediate arm compared to the delayed arm. There was also no evidence that the tracing of sexual partners led to an increase in intimate partner violence.

These results illustrate that assisted partner services can make an important contribution to identifying people living with HIV who are undiagnosed, enabling people to get tested and engaged with care in a low-income setting. A major challenge, identified by the study authors, is whether the human resources would be available in already highly stretched settings to implement this strategy. They suggest that task shifting from professional healthcare providers to a less highly educated cadre of workers would be feasible and point to other areas of care such as safe male circumcision and ART delivery, where this has been successfully achieved. 

Africa
Kenya
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A step forward for HIV prevention in women

Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women.

Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. N Engl J Med. 2016 Dec;375(22):2133-2143.

Background: The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda.

Methods: In this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion.

Results: A total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P=0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified.

Conclusions: Among women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226 .).

Abstract  Full-text [free] access

Editor’s notes: The need to develop safe, effective tools for women, particularly young women and adolescent girls, remains a high priority in sub-Saharan Africa. Self-inserted vaginal rings, which provide sustained release of antiretroviral drugs over time, offer an option that women can initiate themselves. Two large randomised trials have been conducted to assess the efficacy and safety of a vaginal ring containing dapivirine in preventing HIV infection in women. This trial is published in the same issue of the New England Journal of Medicine as the trial by Baeten et al. (reviewed by HIV This Month in March 2016). Both trials were conducted in eastern and southern Africa where the incidence of HIV remains high.

As in the Baeten trial, this trial found a moderate reduction in HIV infection (31% lower) among women using the dapivirine vaginal ring compared with placebo. In both trials, protection was higher among women older than 21 years of age, although, unlike the Baeten trial, the difference in efficacy between the two age groups in this trial was not statistically significant. Baeten et al noted that biological measurement of adherence was higher among women older than 21 years (more than 70% overall) which may partly explain the higher protection observed. The investigators of both trials note that the genital tract of younger women may make them more susceptible to HIV infection. This warrants further investigation. Differences in the frequency of vaginal and/or anal sex across different age groups may also be important. In an editorial to accompany publication of these two important trials, Adimora notes that “providers and women must ensure that the HIV interventions that women adopt match their sexual behaviours and needs. Different women – and women at different life stages – will require different types of HIV prevention.”  

Africa
South Africa, Uganda
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Study finds rectal gel to be safe in men, but not as acceptable for daily use

MTN-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel.

Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. Clin Infect Dis. 2016 Dec 16. pii: ciw832. [Epub ahead of print]

Background: HIV disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.

Methods: MTN-017 was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily; or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI); or daily oral FTC/TDF.

Results: MSM and TGW (n=195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in Grade 2 or higher adverse event rates in participants using daily gel (Incidence Rate Ratio (IRR): 1.09, p=0.59) or RAI gel (IRR: 0.90, p=0.51) compared to FTC/TDF. High adherence (≥80% of prescribed doses as assessed by unused product return and SMS reports) was less likely in the daily gel regimen (Odds Ratio (OR): 0.35, p<0.001) and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR: 0.38, p<0.001).

Conclusions: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.

Abstract access  

Editor’s notes: While microbicide gel to prevent HIV in women has not been consistently shown to be effective, scientific efforts to develop a rectal microbicide gel have continued in the hopes of finding a safe and effective product for HIV prevention in men. This paper presents a phase II clinical trial in which gay men and other men who have sex with men across four different countries were randomly assigned to one of three arms: oral pre-exposure prophylaxis (‘daily oral’), topical gel administered before and after receptive anal intercourse (‘RAI’), and topical gel administered daily (‘daily rectal’). The authors found that the rectal gel was safe to use, and was acceptable to participants, although the daily rectal application had lower acceptability and lower adherence than daily oral or the RAI.  This safety, adherence, and acceptability seen in this Phase II study supports further development of the gel as a rectal microbicide candidate, although consideration will need to be given to dosing regimens to maximize adherence. 

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MSM resilience to HIV

Identifying resilience resources for HIV prevention among sexual minority men: a systematic review.

Woodward EN, Banks RJ, Marks AK, Pantalone DW. AIDS Behav. 2016 Dec 15. [Epub ahead of print]

Most HIV prevention for sexual minority men and men who have sex with men targets risk behaviors (e.g., condom use) and helps <50% of participants. Bolstering resilience might increase HIV prevention's effectiveness. This systematic review identified resilience resources (protective factors) in high-risk, HIV-negative, sexual minority men. We reviewed PsycINFO, PsycARTICLES, MEDLINE, references, and Listservs for studies including sexual minority men with 1+ HIV risk factor (syndemics): childhood sexual abuse, partner abuse, substance abuse, or mental health symptoms. From 1356 articles screened, 20 articles met inclusion criteria. Across the articles, we identified and codified 31 resilience resources: socioeconomic (e.g., employment), behavioral coping strategies (e.g., mental health treatment), cognitions/emotions (e.g., acceptance), and relationships. Resilience resources were generally associated with lower HIV risk; there were 18 low-risk associations, 4 high-risk associations, 8 non-significant associations. We generated a set of empirically based resilience variables and a hypothesis to be evaluated further to improve HIV prevention.

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Editor’s notes: This systematic review sought to identify why gay men and other men who have sex with men, at high-risk of HIV, remain HIV negative. HIV-negative, gay men and other men who have sex with men, with a key risk factor for HIV were identified. These risk factors were childhood sexual abuse, partner abuse, substance abuse or mental health symptoms. The authors sought to identify why such men remain HIV negative. Why they are resilient to infection. Some 20 studies met the inclusion criteria. Four broad categories of resilience were identified; socioeconomic (e.g. degree, full-time job); behavioural coping strategies (e.g. accessing mental health services), cognitions/ emotions (e.g. acceptance of a situation); and relationships (e.g. perceived sufficient social support). Of the 31 sub-categories of resilience resources identified, four were identified as protective for HIV infection: main sex partner is HIV negative, willingness to use PrEP, PrEP acceptance and condom use. Resilience resource research for HIV prevention is a sparse area of study. This study generated a set of resilience variables upon which further research can be built.

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Adolescents’ concerns: psychosocial needs of young people living with HIV in Thailand

Psychosocial needs of perinatally HIV-infected youths in Thailand: lessons learnt from instructive counseling.

Manaboriboon B, Lolekha R, Chokephaibulkit K, Leowsrisook P, Naiwatanakul T, Tarugsa J, Durier Y, Aunjit N, Punpanich Vandepitte W, Boon-Yasidhi V. AIDS Care. 2016 Dec;28(12):1615-1622. Epub 2016 Jun 26.

Identifying psychosocial needs of perinatally HIV-infected (pHIV) youth is a key step in ensuring good mental health care. We report psychosocial needs of pHIV youth identified using the "Youth Counseling Needs Survey" (YCS) and during individual counseling (IC) sessions. pHIV youth receiving care at two tertiary-care hospitals in Bangkok or at an orphanage in Lopburi province were invited to participate IC sessions. The youths' psychosocial needs were assessed using instructive IC sessions in four main areas: general health, reproductive health, mood, and psychosocial concerns. Prior to the IC session youth were asked to complete the YCS in which their concerns in the four areas were investigated. Issues identified from the YCS and the IC sessions were compared. During October 2010-July 2011, 150 (68.2%) of 220 eligible youths participated in the IC sessions and completed the YCS. Median age was 14 (range 11-18) years and 92 (61.3%) were female. Mean duration of the IC sessions was 36.5 minutes. One-hundred and thirty (86.7%) youths reported having at least one psychosocial problem discovered by either the IC session or the YCS. The most common problems identified during the IC session were poor health attitude and self-care (48.0%), lack of life skills (44.0%), lack of communication skills (40.0%), poor antiretroviral (ARV) adherence (38.7%), and low self-value (34.7%). The most common problems identified by the YCS were lack of communication skills (21.3%), poor health attitude and self-care (14.0%), and poor ARV adherence (12.7%). Youth were less likely to report psychosocial problems in the YCS than in the IC session. Common psychosocial needs among HIV-infected youth were issues about life skills, communication skills, knowledge on self-care, ARV adherence, and self-value. YCS can identify pHIV youths' psychosocial needs but might underestimate issues. Regular IC sessions are useful to detect problems and provide opportunities for counseling.

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Editor’s notes: The study reports on the psychological needs of young people who acquired HIV in the perinatal period.  The needs were highlighted during counselling sessions and in a survey conducted as part of the Happy-Teen Programme in Thailand. Young people (age 11-18) who have perinatally acquired HIV were recruited in two hospitals and from a service run by an orphanage linked to one of the hospitals. Young people took part in two individual ‘instructive counselling’ sessions, and two survey sessions for a needs-assessment questionnaire. Participants reported higher levels of needs in the counselling sessions compared to the questionnaire. Key areas of need identified included: health attitudes and self-care (e.g., diet, sleep, drug use); issues with sexual risk and difficulties communicating with sexual partners; HIV treatment adherence problems; concerns about HIV-associated stigma; and concerns about peer pressure. The study illustrates the difference in the quality of findings obtained from data collected via the questionnaire in comparison with data collected via sessions with counsellors. The counsellors were people that the young people knew for some time and trusted. The study highlights the importance of counselling with young people to improve self-esteem and health-associated behaviours.  Counsellors are also important to provide referrals for more severe mental health issues. 

Asia
Thailand
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