Articles tagged as "Reduce sexual transmission"

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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Poor accuracy of self-reported adherence to PrEP versus drug detection in many settings

Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection.

Amico KR, Marcus JL, McMahan V, Liu A, Koester KA, Goicochea P, Anderson PL, Glidden D, Guanira J, Grant R. J Acquir Immune Defic Syndr. 2014 May 21. [Epub ahead of print]

Objective: To evaluate the concordance between adherence estimated by self-report (in-person interview or computer-assisted self-interview [CASI]), in-clinic pill counts, and pharmacy dispensation records and drug detection among participants in a placebo-controlled, pre-exposure prophylaxis (PrEP) HIV prevention trial (iPrEx).

Design: Cross-sectional evaluation of 510 participants who had drug concentration data and matched adherence assessments from their week-24 study visit.

Methods: Self-reported adherence collected via (1) interview and (2) CASI surveys, (3) adherence estimated by pill count, and (4) medication possession ratio (MPR) were contrasted to having a detectable level of drug concentrations (either tenofovir diphosphate [TFV-DP] or emtricitabine triphosphate [FTC-TP]) as well as to having evidence of consistent dosing (TFV-DP>/=16 fmol/10 cells), focusing on positive predictive values (PPV), overall and by research site.

Results: Overall, self-report and pharmacy records suggested high rates of product use (over 90% adherence); however, large discrepancies between these measures and drug detection were noted, which varied considerably between sites (PPV from 34% to 62%). Measures of adherence performed generally well in the US sites, but had poor accuracy in other research locations. MPR outperformed other measures but still had relatively low discrimination.

Conclusions: The sizable discrepancy between adherence measures and drug detection in certain regions highlights the potential contribution of factors that may have incentivized efforts to appear adherent. Understanding the processes driving adherence reporting in some settings, but not others, is essential for finding effective ways to increase accuracy in measurement of product use and may generalize to promotion efforts for open-label PrEP.

Abstract access 

Editor’s notes: This paper discusses the results of a sub-study conducted as part of the iPrEX randomised placebo-controlled trial. This trial tested the efficacy of once daily oral pre-exposure prophylaxis (PrEP) for HIV prevention for men who have sex with men (MSM) and transgender women, in several sites globally. The iPrEX study was the first PrEP efficacy study providing tenofovir-based PrEP which reported positive results. It found a 44% protection against HIV acquisition. After further analysis, researchers discovered that participants with higher adherence rates as measured by drug concentrations in the blood, achieved higher levels of protection. This finding, coupled with analyses of the other PrEP prevention trials, highlighted the need to understand why participants in the trials did not take the PrEP. The study also emphasised the need to develop optimal measures of adherence, support strategies for adherence, and strategies for delivering the programme to those who are motivated to take PrEP, for future research and implementation purposes. This sub-study specifically examined the optimal strategies for measuring adherence, and found that measures relying on self-reporting and pill counts did not reflect drug level concentrations in the blood. The discrepancies with drug levels varied across sites, with wider discrepancies found in the more resource poor settings. The findings indicate a need for qualitative research to confirm suspicions, and to further understand how best to measure adherence, and encourage it, in future HIV prevention research studies. 

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High human papillomavirus prevalence among men in sub-Saharan Africa, especially among individuals living with HIV

Human papillomavirus prevalence among men in sub-Saharan Africa: a systematic review and meta-analysis.

Olesen TB, Munk C, Christensen J, Andersen KK, Kjaer SK. Sex Transm Infect. 2014 May 7. doi: 10.1136/sextrans-2013-051456. [Epub ahead of print]

Background: We performed a systematic review and meta-analysis to summarise the available data on the prevalence of human papillomavirus (HPV) among men in sub-Saharan Africa.

Methods: PubMed and Embase were searched up to 10 March 2014. Random effects meta-analyses were used to calculate a pooled prevalence of any HPV and high-risk (HR) HPV.

Results: A total of 11 studies comprising 9 342 men were identified. We found that HPV is very common among men in sub-Saharan Africa, the prevalence of any HPV ranging between 19.1% and 100%. Using random effects meta-analysis, the pooled prevalence of any HPV was 78.2% (95% CI 54.2 to 91.6) among HIV-positive and 49.4% (95% CI 30.4 to 68.6) among HIV-negative men (p=0.0632). When restricting the analyses to PCR-based studies, the pooled prevalence of any HPV was 84.5% (95% CI 74.2 to 91.2) among HIV-positive and 56.4% (95% CI 49.7 to 62.9) among HIV-negative men (p<0.0001). Of the HPV types included in the nine-valent HPV vaccine, the most common HR HPV types were HPV16 and HPV52, and HPV6 was the most common low-risk HPV type. When examining the prevalence of HPV in relation to age no clear trend was observed.

Conclusions: The prevalence of HPV is high among men in sub-Saharan Africa, which could contribute to the high rates of penile and cervical cancer in this part of the world. Implementation of the prophylactic HPV vaccines could potentially help prevent this large burden of HPV and HPV-associated disease in sub-Saharan Africa.

Abstract access 

Editor’s notes: The majority of cases of penile cancer and ano-genital warts are caused by genotypes of human papillomavirus (HPV) that are included in currently available vaccines. Sub-Saharan Africa has among the highest prevalence of HPV-related infections in the world. This review summarizes HPV prevalence in this region, showing strong evidence of a higher prevalence of HPV in HIV-positive men compared to HIV-negative men. The pooled prevalence of HPV by PCR shows a significant difference in prevalence by HIV status – as is seen for women. The high HPV prevalence may partly explain the higher rate of ano-genital cancer/warts among HIV-positive men. This is important for the consideration of vaccinating men as well as women against HPV in sub-Saharan Africa (although herd immunity through vaccination of women may offer men some protection in the long term). High HPV prevalence among HIV-negative men is also important given that there is some evidence for the association between prevalent penile-HPV and HIV acquisition. The high HPV prevalence may also add to the arguments for rapid scale-up of voluntary medical male circumcision (VMMC) in sub-Saharan Africa, since VMMC has been shown to reduce HPV prevalence and incidence, in addition to HIV incidence.

Africa
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Meta-analysis finds partial support for elevated HIV prevalence among the military

Systematic review and meta-analysis of HIV prevalence among men in militaries in low income and middle income countries. 

Lloyd J, Papworth E, Grant L, Beyrer C, Baral S. Sex Transm Infect. 2014 Apr 7. doi: 10.1136/sextrans-2013-051463. [Epub ahead of print]

Objectives: To determine whether the current HIV prevalence in militaries of low-income and middle-income countries is higher, the same, or lower than the HIV prevalence in the adult male population of those countries.

Methods: HIV prevalence data from low-income and middle-income countries' military men were systematically reviewed during 2000-2012 from peer reviewed journals, clearing-house databases and the internet. Standardised data abstraction forms were used to collect information on HIV prevalence, military branch and sample size. Random effects meta-analyses were completed with the Mantel-Haenszel method comparing HIV prevalence among military populations with other men in each country.

Results: 2 214 studies were retrieved, of which 18 studies representing nearly 150 000 military men across 11 countries and 4 regions were included. Military male HIV prevalence across the studies ranged from 0.06% (n=22 666) in India to 13.8% (n=2 733) in Tanzania with a pooled prevalence of 1.1% (n=147 591). HIV prevalence in male military populations in sub-Saharan Africa was significantly higher when compared with reproductive age (15-49 years) adult men (OR: 2.8, 95% CI 1.01 to 7.81). HIV prevalence in longer-serving male military populations compared with reproductive age adult men was significantly higher (OR: 2.68, 95% CI 1.65 to 4.35).

Conclusions: Our data reveals that across the different settings, the burden of HIV among militaries may be higher or lower than the civilian male populations. In this study, male military populations in sub-Saharan Africa, low-income countries and longer-serving men have significantly higher HIV prevalence. Given the national security implications of the increased burden of HIV, interventions targeting military personnel in these populations should be scaled up where appropriate.

Abstract access 

Editor’s notes: Men in military service are considered a key population because they spend protracted periods away from home and may engage in casual or other high-risk sex. This is not just a health concern for the armed forces themselves, but countries have in the past refused the assistance of peacekeeping forces because they were deemed a source of new infections. This systematic review concludes that HIV infection rates in the military are not universally higher than among men of reproductive age in the general population. However, significantly elevated prevalence was detected in studies from sub-Saharan Africa and among military who have been in service for over one year. The latter suggests that the relatively high prevalence results from increased exposure during service rather than the disproportional recruitment of men with HIV into service. On the contrary, the prevalence among new recruits is lower than in the general population. Prevention efforts, including HIV testing and counselling, and condom distribution, need to be increased during deployment in settings where exposure to HIV is high.

Epidemiology
Africa, Asia, Latin America
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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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Sexual relationship power is unexpectedly not associated with unprotected sex in tavern populations in South Africa

Alcohol use, sexual relationship power, and unprotected sex among patrons in bars and taverns in rural areas of North West Province, South Africa.

Nkosi S, Rich EP, Morojele NK. AIDS Behav. 2014 Apr 4. [Epub ahead of print]

We examined the relative importance of alcohol consumption and sexual relationship power (SRP) in predicting unprotected sex among 406 bar patrons in North West province, South Africa. We assessed participants' demographic characteristics, alcohol consumption, SRP, and number of unprotected sexual episodes in the past 6 months. In correlational analyses, alcohol consumption was significantly associated with frequency of unprotected sex for both males and females. SRP was significantly associated with frequency of unprotected sex for males and marginally associated for females. In multivariate regression analyses, alcohol consumption was significantly associated with frequency of unprotected sex for both males and females. SRP's association was marginally significant for females and not significant for males. Alcohol consumption is more strongly associated with unprotected sex than is SRP among bar patrons. Combination HIV prevention approaches to curb problem drinking and increase condom accessibility, and regular and effective use are needed in tavern settings. SRP needs further examination among tavern populations.

Abstract access 

Editor’s notes: This study examines the relationship between sexual relationship power, (SRP) alcohol use, and unprotected sex in a population of men and women frequenting taverns in the Northwest Province of South Africa. The study participants were recruited at bars in two rural villages and represented regular drinkers. Eligibility criteria included visiting the bar at least once a month. Three-quarters of participants were classified as problem drinkers on the AUDIT scale. Overall, alcohol was related to unprotected sex for both women and men. However, somewhat surprisingly, after adjusting for alcohol use, SRP was not associated with unprotected sex. In South Africa, where gender inequality has been an issue, it is expected that SRP would play a role in acts of unprotected sex. Future research to examine how SRP may be measured more accurately would be useful, but this unexpected result may indicate that there are nuances to SRP that research has not yet taken into account. It is clear, however, that alcohol plays a major role in sexual encounters and condom use. Future HIV prevention research and programming should incorporate structural drivers such as alcohol use in order to design more comprehensive approaches.

Africa
South Africa
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High rates of acute HIV infection in breastfeeding women, with serious implications for mothers and infants

High HIV incidence in the postpartum period sustains vertical transmission in settings with generalized epidemics: a cohort study in Southern Mozambique.

De Schacht C, Mabunda N, Ferreira OC, Ismael N, Calu N, Santos I, Hoffman HJ, Alons C, Guay L, Jani IV. J Int AIDS Soc. 2014 Mar 5;17(1):18808. doi: 10.7448/IAS.17.1.18808. eCollection 2014.

Introduction: Acute infection with HIV in the postpartum period results in a high risk of vertical transmission through breastfeeding. A study was done to determine the HIV incidence rate and associated risk factors among postpartum women in Southern Mozambique, where HIV prevalence among pregnant women is 21%.

Methods: A prospective cohort study was conducted in six rural health facilities in Gaza and Maputo provinces from March 2008 to July 2011. A total of 1 221 women who were HIV-negative on testing at delivery or within two months postpartum were recruited and followed until 18 months postpartum. HIV testing, collection of dried blood spot samples and administration of a structured questionnaire to women were performed every three months. Infant testing by DNA-PCR was done as soon as possible after identification of a new infection in women. HIV incidence was estimated, and potential risk factors at baseline were compared using Poisson regression.

Results: Data from 957 women were analyzed with follow-up after the enrolment visit, with a median follow-up of 18.2 months. The HIV incidence in postpartum women is estimated at 3.20/100 women-years (95% CI: 2.30-4.46), with the highest rate among 18- to 19-year-olds (4.92 per 100 women-years; 95% CI: 2.65-9.15). Of the new infections, 14 (34%) were identified during the first six months postpartum, 11 (27%) between 6 and 12 months and 16 (39%) between 12 and 18 months postpartum. Risk factors for incident HIV infection include young age, low number of children, higher education level of the woman's partner and having had sex with someone other than one's partner. The vertical transmission was 21% (95% CI: 5-36) among newly infected women.

Conclusions: Incidence of HIV is high among breastfeeding women in Southern Mozambique, contributing to increasing numbers of HIV-infected infants. Comprehensive primary prevention strategies targeting women of reproductive age, particularly pregnant and postpartum women and their partners, will be crucial for the elimination of paediatric AIDS in Africa.

Abstract   Full-text [free] access

Editor’s notes: Maternal acquisition of HIV during late pregnancy or the post-partum period has dual importance, because of the consequences not only for the mother, but also the infant. A false sense of security placed on a negative HIV test done in early pregnancy (often during the first antenatal visit) places women and infants at risk from maternal infection acquired later. This study adds to the relatively limited data on HIV acquisition in women who are breastfeeding and transmission to the infant during maternal acute infection. The authors also identify the important limitations of their study. These included the high loss-to-follow-up (LTF) rate, i.e., only 54% of participants completed all steps from enrolment to the endpoint of the study, and the low number of infants identifiable for HIV testing. There was differential LTF, with higher retention of women with educated partners. This could lead to bias in HIV incidence rates. Nonetheless, the results of this study parallel other data from similar settings. It shows high HIV incidence rates during the post-partum period in a high prevalence setting. The proportion of women of reproductive age is 25% of the population in Mozambique. Thus, the population level impact of this high incidence rate, as well as the implications on transmission to the next generation, is highly concerning. The prospects for instituting prevention efforts are challenging. The study suggests focusing testing on women in antenatal clinics is insufficient, even with repeat testing during pregnancy and post-partum, for prevention of mother to child transmission, let alone preventing maternal acquisition. Wider combination prevention efforts, including increasing knowledge of HIV status of male partners, condom promotion, voluntary medical male circumcision and treatment as prevention to reduce HIV at a population level, are needed.  

Africa
Mozambique
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Qualitative research from the VOICE trial reveals women’s challenges in adherence

Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, Schwartz K, Laborde N, Soto-Torres L. PLoS One. 2014 Feb 21;9(2):e89118. doi: 10.1371/journal.pone.0089118. eCollection 2014.

Background: In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants' experience of daily vaginal gel and oral tablet regimens in VOICE.

Methods: In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis.

Results: Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use.

Conclusions: Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women's perceptions of trial participation and experiences with investigational products. Whether these impacted women's behaviors and may have contributed to ineffective trial results warrants further investigation.

Abstract   Full-text [free] access 

Editor’s notes: VOICE C was a qualitative ancillary study looking at experiences of women participating in the larger VOICE clinical trial which tested the efficacy of oral pre-exposure prophylaxis (PrEP) and topical microbicides. Two of the three active study arms for VOICE were stopped early for futility. The third arm continued to the planned completion date, but the activities in this arm were also found to have no effect. In this regard, VOICE C became very important in understanding what happened during the trial, since participants reported a high rate of adherence and we know that PrEP works if taken. Once bloods were analysed to look at drug levels, it was found that few participants were regularly taking the study medication. Data emerging from VOICE C revealed that women elected not to take the drugs due to boredom with the study, issues with side effects and health status, and difficulties managing social relationships. Interestingly, women admitted that they knew other participants were also not taking their study medications. These discussions between women took place when participants were in contact with one another such as in waiting-rooms. Perhaps the major strength of VOICE C was the design, which allowed for triangulation of data sources to create more comprehensive narratives of participants’ experiences. The study employed longitudinal in-depth interviews, serial ethnographic interviews, and focus group discussions which elicited a richness of data which would not have been available otherwise. It is clear from this study that there is much to learn about how clinical trials are conducted to ensure success. Perhaps most importantly, we need to know how participants see their roles and why they agree to be part of the study.

Africa
South Africa
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Complex relationships between voluntary counselling and testing and behaviour change in northwest Tanzania

The impact of voluntary counselling and testing services on sexual behaviour change and HIV incidence: observations from a cohort study in rural Tanzania.

Cawley C, Wringe A, Slaymaker E, Todd J, Michael D, Kumugola Y, Urassa M, Zaba B. BMC Infect Dis. 2014 Mar 22;14:159. doi: 10.1186/1471-2334-14-159.

Background: It is widely assumed that voluntary counselling and testing (VCT) services contribute to HIV prevention by motivating clients to reduce sexual risk-taking. However, findings from sub-Saharan Africa have been mixed, particularly among HIV-negative persons. We explored associations between VCT use and changes in sexual risk behaviours and HIV incidence using data from a community HIV cohort study in northwest Tanzania.

Methods: Data on VCT use, sexual behaviour and HIV status were available from three HIV serological surveillance rounds undertaken in 2003-4 (Sero4), 2006-7 (Sero5) and 2010 (Sero6). We used multinomial logistic regression to assess changes in sexual risk behaviours between rounds, and Poisson regression to estimate HIV incidence.

Results: The analyses included 3 613 participants attending Sero4 and Sero5 (3 474 HIV-negative and 139 HIV-positive at earlier round) and 2 998 attending Sero5 and Sero6 (2 858 HIV-negative and 140 HIV-positive at earlier round). Among HIV-negative individuals VCT use was associated with reductions in the number of sexual partners in the last year (aRR Seros 4-5: 1.42, 95% CI 1.07-1.88; aRR Seros 5-6: 1.68, 95% CI 1.25-2.26) and in the likelihood of having a non-cohabiting partner in the last year (aRR Seros 4-5: 1.57, 95% CI 1.10-2.25; aRR Seros 5-6: 1.48, 95% CI 1.07-2.04) or a high-risk partner in the last year (aRR Seros 5-6 1.57, 95% CI 1.06-2.31). However, VCT was also associated with stopping using condoms with non-cohabiting partners between Seros 4-5 (aRR 4.88, 95% CI 1.39-17.16). There were no statistically significant associations between VCT use and changes in HIV incidence, nor changes in sexual behaviour among HIV-positive individuals, possibly due to small sample sizes.

Conclusions: We found moderate associations between VCT use and reductions in some sexual risk behaviours among HIV-negative participants, but no impacts among HIV-positive individuals in the context of low overall VCT uptake. Furthermore, there were no significant changes in HIV incidence associated with VCT use, although declining background incidence and small sample sizes may have prevented us from detecting this. The impact of VCT services will ultimately depend upon rates of uptake, with further research required to better understand processes of behaviour change following VCT use.

Abstract   Full-text [free] access

Editor’s notes: This study focused on seven years of serological surveillance surveys and voluntary counselling and testing data (VCT) from a community cohort in northwest Tanzania. The aim of the study was to examine correlations between VCT use and changes in sexual behaviour. In general, it is often assumed that VCT helps to reduce HIV incidence by making people aware of HIV and their status. However, further investigation in previous studies has shown that this is not always the case. This particular study revealed relatively low uptake of VCT and low condom use, but VCT was associated with a reduction of sexual partners in HIV-negative individuals. The study was unable to detect a significant association between HIV incidence and VCT, nor any changes in behaviour among HIV-positive individuals. It is clear from the nuanced results of this study that relationships between VCT and behaviour change are complex and variable. Qualitative research would help us to understand what other issues influence this relationship and could shed light on the low uptake of VCT in this area. Perhaps an updated systematic review of VCT and sexual behaviour studies in combination with qualitative research could help in better understanding this dynamic relationship.

Africa
United Republic of Tanzania
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