Articles tagged as "Africa"

Home-based HIV testing more effective than community testing, but fewer linked to care

A comparison of home-based versus outreach event-based community HIV testing in Ugandan fisherfolk communities.

Bogart LM, Wagner GJ, Musoke W, Naigino R, Linnemayr S, Maistrellis E, Klein DJ, Jumamil RB, Mukasa B, Bassett IV, Giordano TP, Wanyenze RK. AIDS Behav. 2016 Nov 29. [Epub ahead of print]

We compared two community-based HIV testing models among fisherfolk in Lake Victoria, Uganda. From May to July 2015, 1364 fisherfolk residents of one island were offered (and 822 received) home-based testing, and 344 fisherfolk on another island were offered testing during eight community mobilization events (outreach event-based testing). Of 207 home-based testing clients identified as HIV-positive (15% of residents), 82 were newly diagnosed, of whom 31 (38%) linked to care within 3 months. Of 41 who screened positive during event-based testing (12% of those tested), 33 were newly diagnosed, of whom 24 (75%) linked to care within 3 months. Testing costs per capita were similar for home-based ($45.09) and event-based testing ($46.99). Compared to event-based testing, home-based testing uncovered a higher number of new HIV cases but was associated with lower linkage to care. Novel community-based test-and-treat programs are needed to ensure timely linkage to care for newly diagnosed fisherfolk.

Abstract access  

Editor’s notes: Regular and reliable HIV testing is necessary to ensure that people who need antiretroviral treatment know their status. When someone tests positive for HIV, it is critical that they are linked to care. This study compares two different types of HIV testing among fisherfolk in Uganda – home-based and community event-based testing. The authors find that home-based testing uncovered more people living with HIV than community event-based testing, but a lower proportion of people were successfully linked to care. The costs of both types of testing were similar. Fewer new people living with HIV were identified through community event-based testing. People who know that they are HIV positive are perhaps more likely to attend such events than people who have not sought to be tested recently, or who are HIV negative. Home-based testing requires less effort from persons receiving a test, and therefore may reach people less likely to test independently. This study further emphasises that linkage to care is a critical step in the HIV treatment cascade.

HIV testing
Africa
Uganda
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At the halfway mark? Community viral suppression in East Africa

Population levels and geographical distribution of HIV RNA in rural Ugandan and Kenyan communities, including serodiscordant couples: a cross-sectional analysis.

Jain V, Petersen ML, Liegler T, Byonanebye DM, Kwarisiima D, Chamie G, Sang N, Black D, Clark TD, Ladai A, Plenty A, Kabami J, Ssemmondo E, Bukusi EA, Cohen CR, Charlebois ED, Kamya MR, Havlir DV. Lancet HIV. 2016 Dec 15. pii: S2352-3018(16)30220-X. doi: 10.1016/S2352-3018(16)30220-X. [Epub ahead of print]

Background: As sub-Saharan Africa transitions to a new era of universal antiretroviral therapy (ART), up-to-date assessments of population-level HIV RNA suppression are needed to inform interventions to optimise ART delivery. We sought to measure population viral load metrics to assess viral suppression and characterise demographic groups and geographical locations with high-level detectable viraemia in east Africa.

Methods: The Sustainable East Africa Research in Community Health (SEARCH) study is a cluster-randomised controlled trial of an HIV test-and-treat strategy in 32 rural communities in Uganda and Kenya, selected on the basis of rural setting, having an approximate population of 10 000 people, and being within the catchment area of a President's Emergency Plan for AIDS Relief-supported HIV clinic. During the baseline population assessment in the SEARCH study, we did baseline HIV testing and HIV RNA measurement. We analysed stable adult (aged 15 years) community residents. We defined viral suppression as a viral load of less than 500 copies per mL. To assess geographical sources of transmission risk, we established the proportion of all adults (both HIV positive and HIV negative) with a detectable viral load (local prevalence of viraemia). We defined transmission risk hotspots as geopolitical subunits within communities with an at least 5% local prevalence of viraemia. We also assessed serodiscordant couples, measuring the proportion of HIV-positive partners with detectable viraemia. The SEARCH study is registered with ClinicalTrials.gov, number NCT01864603.

Findings: Between April 2, 2013, and June 8, 2014, of 303 461 stable residents, we enumerated 274 040 (90.3%), of whom 132 030 (48.2%) were adults. Of these, 117 711 (89.2%) had their HIV status established, of whom 11 964 (10.2%) were HIV positive. Of these, we measured viral load in 8828 (73.8%) people. Viral suppression occurred in 3427 (81.6%) of 4202 HIV-positive adults on ART and 4490 (50.9%) of 8828 HIV-positive adults. Regional viral suppression among HIV-positive adults occurred in 881 (48.2%) of 1827 people in west Uganda, 516 (45.0%) of 1147 in east Uganda, and 3093 (52.8%) of 5854 in Kenya. Transmission risk hotspots occurred in three of 21 parishes in west Uganda and none in east Uganda and in 24 of 26 Kenya geopolitical subunits. In Uganda, 492 (2.9%) of 16 874 couples were serodiscordant: in 287 (58.3%) of these couples, the HIV-positive partner was viraemic (and in 69 [14.0%], viral load was >100 000 copies per mL). In Kenya, 859 (10.0%) of 8616 couples were serodiscordant: in 445 (53.0%) of these couples, the HIV-positive partner was viraemic (and in 129 [15%], viral load was >100 000 copies per mL).

Interpretation: Before the start of the SEARCH trial, 51% of east African HIV-positive adults had viral suppression, reflecting ART scale-up efforts to date. Geographical hotspots of potential HIV transmission risk and detectable viraemia among serodiscordant couples warrant intensified interventions.

Abstract access  

Editor’s notes: Half of all people living with HIV with a valid viral load measurement in these East African communities had viral suppression (<500 copies/mL) at the start of this cluster randomised trial in 2013-14. These results already provided good evidence of the effectiveness and impact of antiretroviral programmes in East Africa. However, at the AIDS conference in July 2016 the study group presented updated results following two years of a universal test and treat (UTT) strategy with expansion of community-based HIV testing services (access abstract here). By this point, the UNAIDS 90-90-90 treatment target had been exceeded in the study communities and, overall, 82% of people living with HIV had viral suppression. 

These results highlight the role of community viral load metrics as indicators of programme impact. What gives rise to more debate is the role of these metrics in estimating the risk of ongoing HIV transmission in the community. Consensus seems to be emerging that the population prevalence of viraemia may be the metric best suited for this purpose. In this study, the estimated population prevalence of viraemia varied quite widely from 0.5 to 14.1% at the level of local communities (of between around 500 and 5000 people). This measure was also used to define several transmission hotspots, based on an arbitrary cut-off of five percent prevalence of viraemia.

Additional research is necessary in different epidemiological contexts to understand the association between these metrics and risk of HIV transmission. There is also some way to go to understand if such metrics can have practical public health implications for HIV prevention. Whether revealing such heterogeneity in transmission risk within generalized epidemics can inform the application of geographically focussed programmes is a question that now should be addressed.

Africa
Kenya, Uganda
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Creating welcoming spaces for men’s active involvement

What do you need to get male partners of pregnant women tested for HIV in resource limited settings? The baby shower cluster randomized trial.

Ezeanolue EE, Obiefune MC, Yang W, Ezeanolue CO, Pharr J, Osuji A, Ogidi AG, Hunt AT, Patel D, Ogedegbe G, Ehiri JE. AIDS Behav. 2016 Dec 8. [Epub ahead of print]

Male partner involvement has the potential to increase uptake of interventions to prevent mother-to-child transmission of HIV (PMTCT). Finding cultural appropriate strategies to promote male partner involvement in PMTCT programs remains an abiding public health challenge. We assessed whether a congregation-based intervention, the Healthy Beginning Initiative (HBI), would lead to increased uptake of HIV testing among male partners of pregnant women during pregnancy. A cluster-randomized controlled trial of forty churches in Southeastern Nigeria randomly assigned to either the HBI (intervention group; IG) or standard of care referral to a health facility (control group; CG) was conducted. Participants in the IG received education and were offered onsite HIV testing. Overall, 2498 male partners enrolled and participated, a participation rate of 88.9%. Results showed that male partners in the IG were 12 times more likely to have had an HIV test compared to male partners of pregnant women in the CG (CG = 37.71% vs. IG = 84.00%; adjusted odds ratio = 11.9; p < .01). Culturally appropriate and community-based interventions can be effective in increasing HIV testing and counseling among male partners of pregnant women.

Abstract  Full-text [free] access

Editor’s notes: Barriers to male partner participation in antenatal care in sub-Saharan Africa include the timing of antenatal services during work hours and negative health care provider attitudes. Importantly, they also include gender norms against male participation that are anchored in deep-seated perceptions that pregnancy is a woman’s affair. This highly successful trial resulted in verified HIV testing by 84% of male partners in the programme group and 38% in the control group, well above the overall HIV testing uptake by males in Nigeria at the time of 23%. What were the elements of the programme that contributed to its success? Critically, it was conducted in communities where religious institutions and their leaders have strong community influence and where nearly 90% of the population attends places of worship. Next, it proposed integrated testing (haemoglobin, malaria, sickle cell genotype, HIV, hepatitis B, and syphilis) to reduce stigma associated with HIV testing. It included the haemoglobin test because men indicated in the formative stages that they wanted this test to find out how strong they were. Then, it engaged the couples publically, with the religious leader inviting all pregnant women and their partners each Sunday to approach the altar for a prayer, accompanied by information about the baby shower programme and the importance of antenatal care. The programme ran baby showers monthly for all participants with the programme group playing an educational game and being offered free integrated HIV testing. The control group was referred to a local health facility for antenatal care and free HIV testing. At baby receptions held every two to three months, the control groups were offered free integrated HIV testing. All in all, HIV testing for male partners was convenient, free, and integrated with other tests that men wanted. It was provided in a family-centred, congregation-based enabling environment that supported men to step forward with their pregnant partners to learn their HIV status. Such a strategy could work in other settings where influential community leaders are prepared to lead the design and implementation of innovative HIV prevention programmes that resonate with community cultural and spiritual values.

Africa
Nigeria
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ART has dramatically improved life expectancy for people living with HIV in KwaZulu-Natal, South Africa

Trends in the burden of HIV mortality after roll-out of antiretroviral therapy in KwaZulu-Natal, South Africa: an observational community cohort study.

Reniers G, Blom S, Calvert C, Martin-Onraet A, Herbst AJ, Eaton JW, Bor J, Slaymaker E, Li ZR, Clark SJ, Barnighausen T, Zaba B, Hosegood V Lancet HIV. 2016 Dec 9. pii: S2352-3018(16)30225-9. doi: 10.1016/S2352-3018(16)30225-9

Background: Antiretroviral therapy (ART) substantially decreases morbidity and mortality in people living with HIV. In this study, we describe population-level trends in the adult life expectancy and trends in the residual burden of HIV mortality after the roll-out of a public sector ART programme in KwaZulu-Natal, South Africa, one of the populations with the most severe HIV epidemics in the world.

Methods: Data come from the Africa Centre Demographic Information System (ACDIS), an observational community cohort study in the uMkhanyakude district in northern KwaZulu-Natal, South Africa. We used non-parametric survival analysis methods to estimate gains in the population-wide life expectancy at age 15 years since the introduction of ART, and the shortfall of the population-wide adult life expectancy compared with that of the HIV-negative population (ie, the life expectancy deficit). Life expectancy gains and deficits were further disaggregated by age and cause of death with demographic decomposition methods.

Findings: Covering the calendar years 2001 through to 2014, we obtained information on 93 903 adults who jointly contribute 535 428 person-years of observation to the analyses and 9992 deaths. Since the roll-out of ART in 2004, adult life expectancy increased by 15.2 years for men (95% CI 12.4-17.8) and 17.2 years for women (14.5-20.2). Reductions in pulmonary tuberculosis and HIV-related mortality account for 79.7% of the total life expectancy gains in men (8.4 adult life-years), and 90.7% in women (12.8 adult life-years). For men, 9.5% is the result of a decline in external injuries. By 2014, the life expectancy deficit had decreased to 1.2 years for men (-2.9 to 5.8) and to 5.3 years for women (2.6-7.8). In 2011-14, pulmonary tuberculosis and HIV were responsible for 84.9% of the life expectancy deficit in men and 80.8% in women.

Interpretation: The burden of HIV on adult mortality in this population is rapidly shrinking, but remains large for women, despite their better engagement with HIV-care services. Gains in adult life-years lived as well as the present life expectancy deficit are almost exclusively due to differences in mortality attributed to HIV and pulmonary tuberculosis.

Abstract access

Editor’s notes: Health and demographic surveillance system (HDSS) sites allow for monitoring of population health through the collection of detailed data on tens of thousands of individuals. Such sites in countries with high HIV prevalence have played an important role in measuring the effects of large-scale programmes, such as the global roll-out of antiretroviral therapy (ART). The data presented in this paper, from the Africa Centre Demographic Information System (ACDIS) in KwaZulu-Natal, South Africa, span 13 years (2001–14) and represent over 93 000 individuals living in an area with extremely high HIV prevalence (29% in adults aged 15–49 years in 2011). At least 15 000 of people studied were HIV-positive, of whom at least 2000 died. ART was first made available to people living with HIV (PLHIV) in this area in 2004.

Among adults aged 15–49 years, the authors report an overall reduction in death rate from 2001–14.  This translates into large increases in life expectancy (i.e., the expected number of years lived from age 15) of 15 and 17 years for men and women, respectively, between 2001 and 2014.  The changes in life expectancy are greater in people who were confirmed HIV-positive: 18 and 21 years for men and women, respectively, from 2007–14.  The large difference in life expectancies between the sexes that still exists (31 versus 44 years in HIV-positive men and women, respectively) are consistent with previously published estimates from Rwanda and Uganda. This study, however, illustrates that HIV-positive men are catching up to their HIV-negative counterparts faster than women are. The ‘deficit’ in 2014 - the gap in life expectancies between HIV-positive and HIV-negative individuals, was 1.2 years in men but still 5.3 years in women.

The authors propose that increased access to ART is the primary driver of the gains in life expectancy seen in this cohort. To further support this, they include data from verbal autopsies (VAs), which suggest that reductions in deaths due to HIV and pulmonary tuberculosis were responsible for 80% and 90% of the increases in life expectancy in men and women, respectively. VAs have limitations, however, particularly in areas of high HIV prevalence, but the overall mortality patterns suggested by these findings are likely to be accurate, even if the precise estimates differ.

The dramatic increases in life expectancy, in only seven years, for HIV-positive individuals in this cohort add to the encouraging observations from other low- and middle-income countries that many people receiving ART can expect to live for nearly as long as HIV-negative individuals.  Of course, people with advanced disease starting ART are still at high risk of death and there remain considerable challenges in getting treatment to all people in need of it. 

Africa
South Africa
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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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Is universal antenatal HIV testing still cost-effective?

Should HIV testing for all pregnant women continue? Cost-effectiveness of universal antenatal testing compared to focused approaches across high to very low HIV prevalence settings.

Ishikawa N, Dalal S, Johnson C, Hogan DR, Shimbo T, Shaffer N, Pendse RN, Lo YR, Ghidinelli MN, Baggaley R. J Int AIDS Soc. 2016 Dec 14;19(1):21212. doi: 10.7448/IAS.19.1.21212. eCollection 2016.

Introduction: HIV testing is the entry point for the elimination of mother-to-child transmission of HIV. Decreasing external funding for the HIV response in some low- and middle-income countries has triggered the question of whether a focused approach to HIV testing targeting pregnant women in high-burden areas should be considered. This study aimed at determining and comparing the cost-effectiveness of universal and focused HIV testing approaches for pregnant women across high to very low HIV prevalence settings.

Methods: We conducted a modelling analysis on health and cost outcomes of HIV testing for pregnant women using four country-based case scenarios (Namibia, Kenya, Haiti and Viet Nam) to illustrate high, intermediate, low and very low HIV prevalence settings. We used subnational prevalence data to divide each country into high-, medium- and low-burden areas, and modelled different antenatal and testing coverage in each.

Results: When HIV testing services were only focused in high-burden areas within a country, mother-to-child transmission rates remained high ranging from 18 to 23%, resulting in a 25 to 69% increase in new paediatric HIV infections and increased future treatment costs for children. Universal HIV testing was found to be dominant (i.e. more QALYs gained with less cost) compared to focused approaches in the Namibia, Kenya and Haiti scenarios. The universal approach was also very cost-effective compared to focused approaches, with $ 125 per quality-adjusted life years gained in the Viet Nam-based scenario of very low HIV prevalence. Sensitivity analysis further supported the findings.

Conclusions: Universal approach to antenatal HIV testing achieves the best health outcomes and is cost-saving or cost-effective in the long term across the range of HIV prevalence settings. It is further a prerequisite for quality maternal and child healthcare and for the elimination of mother-to-child transmission of HIV.

Abstract  Full-text [free] access 

Editor’s notes: This paper describes research undertaken to support the consolidated guidelines on HIV testing services, published by World Health Organization in 2015. This analysis was conducted in response to growing questions as to whether focused HIV testing in high prevalence areas can improve value for money in investment for HIV testing.

A model was parameterized to represent four scenarios with high, intermediate, low, and very low HIV prevalence settings (Namibia, Kenya, Haiti, and Viet Nam). Three approaches to HIV testing in antenatal care are considered in comparison with current coverage in each setting. These three approaches were: a very focused approach, a targeted approach, and a universal testing approach for all pregnant women.  The authors estimate the costs and effects of each scenario, including the future costs of treating paediatric HIV for 20 years. Universal testing was found to be cost-saving in Namibia, Kenya and Haiti and was found to be cost-effective in Viet Nam ($125 per QALY gained).  The targeted testing approach was also more cost-effective than current coverage in all settings.

The clear policy implication from this analysis is that HIV testing for pregnant women saves both money and lives in the long term. Universal HIV testing in antenatal care can be regarded as a good investment in almost any HIV prevalence setting. However, it is also important to note that targeted testing was more cost-effective than current coverage in all settings. Countries that are currently struggling to provide testing in antenatal care may need to consider factors other than cost-effectiveness in their planning and strategy for scaling up. This is important in order to address HIV at a national scale.  

Africa, Asia, Latin America
Haiti, Kenya, Namibia, Viet Nam
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Lies in clinical trials – the truth about data accuracy

Misreporting of product adherence in the MTN-003/VOICE trial for HIV prevention in Africa: participants' explanations for dishonesty.

Montgomery ET, Mensch B, Musara P, Hartmann M, Woeber K, Etima J, van der Straten. AIDS Behav. 2016 Nov 17. [Epub ahead of print]

Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors circulating in clinic waiting-rooms and surrounding communities. Prevailing power hierarchies between staff and participants may exacerbate misreporting. Participants recognized and suggested that objective, real-time feedback is needed to encourage honest reporting.

Abstract access  

Editor’s notes: The authors of this insightful paper set out the reasons women gave in a trial of vaginal and oral programmes for inaccurately reporting their behaviour during the trial.  The authors could conduct this study because biologic/pharmacokinetic data were available which showed evidence of product use. These data were shared with individual women. None of the reasons women gave for not telling the truth is surprising. They lied to avoid additional questioning from research staff.  They feared telling the truth would result in being removed from the trial. They feared beingreprimanded. Overall, not telling the truth about product use helped them save face and time. The findings do highlight the power difference between researchers and researched, something that is hard to avoid in many areas of research. This difference was exacerbated in some circumstances by the (reported) harsh behaviour of staff towards women. The ease with which women could manipulate pill counts or product use checks, by discarding unused product is also not surprising.  The perception by some women that the researchers had lied, because of changes in the trial part way through, is important to note. This highlights the importance of clear information when a trial is explained as it begins. It also points to the importance of continuous explanations and checking participant understanding. It cannot be assumed that there is a shared understanding between researcher and researched. This is something that is easily overlooked as a trial progresses and routine visits are established. The authors highlight the value of objective measures on product use.  They also observe that some participants suggested objective, real-time feedback, during trials.  However, the authors also note that for many women lying about aspects of their lives to partners and family, was a way of managing their lives. It could be that ‘real time feedback’ would act as a deterrent to participation for some in such circumstances.  No system of data collection is perfect.  It is, however, very useful to have a timely reminder that no interview data, however collected, can be assumed to be wholly accurate.    

Africa
South Africa, Uganda, Zimbabwe
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Improving ART adherence: what works?

Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis.

Kanters S, Park JJ, Chan K, Socias ME, Ford N, Forrest JI, Thorlund K, Nachega JB, Mills EJ. Lancet HIV. 2017 Jan;4(1):e31-e40. doi: 10.1016/S2352-3018(16)30206-5. Epub 2016 Nov 16.

Background: High adherence to antiretroviral therapy is crucial to the success of HIV treatment. We evaluated comparative effectiveness of adherence interventions with the aim of informing the WHO's global guidance on interventions to increase adherence.

Methods: For this systematic review and network meta-analysis, we searched for randomised controlled trials of interventions that aimed to improve adherence to antiretroviral therapy regimens in populations with HIV. We searched Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for reports published up to July 16, 2015, and searched major conference abstracts from Jan 1, 2013, to July 16, 2015. We extracted data from eligible studies for study characteristics, interventions, patients' characteristics at baseline, and outcomes for the study populations of interest. We used network meta-analyses to compare adherence and viral suppression for all study settings (global network) and for studies in low-income and middle-income countries only (LMIC network).

Findings: We obtained data from 85 trials with 16 271 participants. Short message service (SMS; text message) interventions were superior to standard of care in improving adherence in both the global network (odds ratio [OR] 1.48, 95% credible interval [CrI] 1.00-2.16) and in the LMIC network (1.49, 1.04-2.09). Multiple interventions showed generally superior adherence to single interventions, indicating additive effects. For viral suppression, only cognitive behavioural therapy (1.46, 1.05-2.12) and supporter interventions (1.28, 1.01-1.71) were superior to standard of care in the global network; none of the interventions improved viral response in the LMIC network. For the global network, the time discrepancy (whether the study outcome was measured during or after intervention was withdrawn) was an effect modifier for both adherence to antiretroviral therapy (coefficient estimate -0.43, 95% CrI -0.75 to -0.11) and viral suppression (-0.48; -0.84 to -0.12), suggesting that the effects of interventions wane over time.

Interpretation: Several interventions can improve adherence and viral suppression; generally, their estimated effects were modest and waned over time.

Abstract access  

Editor’s notes: Maintaining adherence to self-administered medications is difficult. On average, people who are prescribed medications for chronic diseases take fewer than half the prescribed doses. Evidence suggests that in most settings adherence to antiretroviral therapy (ART) is better than this, but there will always be people that struggle to maintain the high levels of adherence required for durable virologic suppression. In this analysis, there was some evidence that specific activities or combinations of activities improved virologic suppression. However, the effect sizes were small and when the analysis was confined to studies in low-income and middle-income countries, there was no evidence to suggest an effect on virologic suppression. Overall the evidence to support any particular activity or combination of activities was not compelling.     

Findings from this analysis have been incorporated into most recent consolidated ART guidelines from the World Health Organization. Trying to summarize complex evidence in this way creates many challenges. Trials were conducted in different populations. Some with all people starting ART, others with people considered to have high risk of suboptimal adherence, and others with people who already had adherence problems. The trials also naturally would have differed in content and quality of the usual package of care to support adherence (the comparator for most programme). 60% of the trials were conducted exclusively in the United States, while others were conducted across different settings.

These are just some of the things that make it difficult to synthesize this evidence into guidance that can be applicable to people living with HIV worldwide. HIV programmes in countries have to decide whether or not to adopt any of these activities that are recommended by WHO on the basis of relatively weak evidence. Would we expect activities aimed at improving adherence to be generalizable across different settings? One might argue probably not. Adherence is a multifactorial, dynamic process and there is unlikely to be a ‘one size fits all’ approach to supporting adherence. In the absence of better evidence for any specific activity, we should perhaps focus on improving the quality of the basic package of adherence support offered to all people receiving ART, while also developing better ways to identify when certain people might benefit from enhanced support.        

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Closing the HIV testing gap with partner-delivered self-testing

Promoting partner testing and couples testing through secondary distribution of HIV self-tests: a randomized clinical trial.

Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166. eCollection 2016.

Background: Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.

Methods and findings: We conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.

Conclusions: Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.

Trial registration: ClinicalTrials.gov NCT02386215.

Abstract  Full-text [free] access 

Editor’s notes: Despite scale-up of HIV testing services, two in every five people living with HIV remain undiagnosed. World Health Organization (WHO) has just issued updated guidance on HIV testing services (HTS). In an effort to plug this testing gap, it strengthened the recommendation that HIV self-testing (HIVST) should be offered as one of the approaches to HTS. This paper adds to the body of evidence supporting that recommendation and provides more insight into the specific role of partner-delivered self-testing.     

There are challenges with conducting clinical trials of HIVST, one of which is selecting an appropriate outcome measure. In this trial, the primary outcome was participant report of male partner testing within three months of enrolment. Overall, uptake of male partner testing as reported by the participants was surprisingly high. It is worth noting that the participants and their partners may not have been particularly hard-to-reach groups. Almost all were married. The female participants were frequent testers. On average, they had tested three times in the past year. Most participants also reported that their male partner had tested at least once in the past year. It should also be noted that many women that were screened chose not to participate, so the participants may have to some extent pre-selected themselves as more interested and more likely to benefit from the activity.   

There were very few male partners reported as testing HIV positive during follow-up. This study was not able to determine how effectively people linked to care after HIVST. This is one of a number of research questions that remain around the delivery and impact of HIVST. Many of these are being addressed by the large HIV Self-Testing Africa (STAR) Project (http://hivstar.lshtm.ac.uk/). What seems to be beyond debate now though is that HIVST can and should play a role in helping us to achieve the UNAIDS 90-90-90 treatment target.   

Africa
Kenya
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