4discuss Any Ethical Concerns With Regard to Using Arts as Prep in Hivnegative Persons
Enquiry Article
Revised
Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open up-label demonstration project in East Africa
[version ii; peer review: 2 approved]
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Respective writer: Renee Heffron Competing interests: Gilead Sciences donated the PrEP medication simply had no role in data collection or analysis. The authors disclosed no competing interests.
Grant information: Pecker and Melinda Gates Foundation [OPP1056051], National Constitute of Mental Health of the Usa National Institutes of Health [R01MH095507] and the United States Agency for International Evolution [AID-OAA-A-12-00023]. This work was too supported by NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK of the National Institutes of Health [AI027757].
This work is made possible by the generous support of the American people through USAID; the contents are the responsibility of the authors and do not necessarily reverberate the views of USAID, NIH, or the The states Regime.
The funders had no part in study design, data drove and analysis, decision to publish, or preparation of the manuscript.
Copyright: © 2018 Heffron R et al. This is an open up access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in whatever medium, provided the original piece of work is properly cited. How to cite: Heffron R, Ngure K, Odoyo J et al. Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, utilise, and effectiveness in an open-characterization demonstration project in East Africa [version 2; peer review: ii approved]. Gates Open up Res 2018, ane:3 (https://doi.org/10.12688/gatesopenres.12752.two) Start published: 06 Nov 2017, ane:3 (https://doi.org/10.12688/gatesopenres.12752.1) Latest published: xxx Jan 2018, ane:3 (https://doi.org/10.12688/gatesopenres.12752.2)
Introduction
Pre-exposure prophylaxis (PrEP) is a new intervention to contribute to control of the global HIV epidemic1–4. Delivery systems for PrEP that maximize touch on and sustainability, while minimizing cost are ideal, especially in settings with limited resources and large numbers of people with substantial risk for HIV. Approaches that synergize with existing health programs – including HIV treatment, family planning, HIV testing and counseling, and antenatal care – can capitalize on opportunities that come with existing infrastructure and community wellness-seeking behavior, easing the process for introducing PrEP.
Demonstration projects are needed to innovate PrEP in different settings, target individuals with dissimilar levels of HIV adventure, and airplane pilot PrEP integration into different public health programs. Through sit-in projects, implementers tin can gauge the infrastructure needed to provide and scale upwards an intervention and how individuals incorporate a new intervention into their life5. They tin as well identify populations which will easily prefer a new intervention and which populations need targeted need creation tools. For PrEP, demonstration projects were initiated immediately following clinical trials and continue to identify models that maximize adherence and create demand among people who are the best candidatessix.
Partnerships betwixt HIV-negative persons and people living with HIV, i.e. serodiscordant couples, have a loftier risk for manual in the absenteeism of HIV prevention interventions and are thus a priority population for delivery of novel HIV prevention tools. Because HIV transmission risk is greatest prior to initiation of antiretroviral therapy (ART) and consequent viral suppression in the partner living with HIV, PrEP tin can be a time-limited intervention for periods without ART use and/or viral suppression. Furthermore, when PrEP and Art are offered together as components of combination HIV prevention programs, couples take multiple options and can be encouraged to adopt strategies based on their preferences and true run a risk factors, in addition to continuous encouragement for sustained Fine art employ by the partner living with HIV.
We conducted a demonstration project of PrEP for HIV prevention among HIV serodiscordant couples attending four HIV intendance clinics in East Africa. Acting results, focusing on HIV incidence reduction from this projection, were previously reportedseven. Hither, we present the last results from 2 years of follow up, including estimates of intervention effectiveness and patterns of PrEP uptake and utilise.
Methods
Study design. The Partners Demonstration Project (clinicaltrials.gov #NCT02775929) was an open-characterization evaluation of integrated delivery of PrEP and ART for loftier adventure HIV serodiscordant couples. Iv clinics located in Kampala and Kabwohe in Republic of uganda and Thika and Kisumu in Republic of kenya were engaged to deliver the intervention; all clinics were HIV care centers and also had feel with HIV prevention research. Whenever possible, operations for the intervention were designed to mirror implementation strategies used in public clinics, such as the use of text messages to remind participants about dispensary appointments, and so every bit to develop a scalable delivery approach.
Each clinic recruited HIV serodiscordant couples through referrals from voluntary counseling and testing centers, antenatal clinics, and ART clinics, and by conducting community outreach events that promoted couples-based HIV testing. Eligible couples were ≥18 years of age, sexually active, and intending to remain as a couple for at to the lowest degree one year. At the time of enrollment, HIV-negative partners had never used PrEP, had normal renal office (defined every bit an estimated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation with ideal body weight), were not infected with hepatitis B virus, and were not pregnant or breastfeeding. At enrollment, HIV-positive partners were not using Fine art and couples were excluded if the HIV-positive partner had WHO stage Three or Iv HIV disease weather that indicated immediate need for Art. In addition, an explicit goal of the project was to recruit couples at loftier chance of HIV conquering, in club to demonstrate PrEP delivery in couples about likely to benefit from the intervention. For that reason, couples were eligible but if they scored at least 5 points on a validated, empiric risk scoring tool which included variables for: age of the HIV-negative partner, marital status of the couple, any condomless sexual practice inside the couple during the past 30 days, male person circumcision status of the HIV-negative partner, and HIV viral load of the partner living with HIVviii,9. Couples were encouraged to attend written report visits together, scheduled i month after enrollment, two months later, and every three months thereafter for up to 24 months. At all visits, couples were offered comprehensive couples-based HIV prevention counseling, including condoms and syndromic management of sexually transmitted infections.
PrEP delivery. At enrollment, co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) was offered to all HIV-negative participants as PrEP with a daily dosing schedule; participants electing non to initiate PrEP at enrollment were offered PrEP initiation at subsequent visits. PrEP was prescribed and dispensed at each study visit with participants being given ane, ii, or iii bottles corresponding to the time until their next appointment engagement. Adherence counseling for PrEP was conducted using streamlined messages with a focus on individual barriers to daily utilise and methods to overcome barriersten. For participants using PrEP, serum creatinine was measured i month after initiation and every half dozen months thereafter. Creatinine confirmatory testing was conducted in cases of a Grade 1 or higher elevation. PrEP was temporarily withheld pending confirmatory testing if the creatinine elevation was Grade two or higher. PrEP was permanently discontinued for confirmed Grade 2 or higher events or if creatinine clearance was <50mL/min.
Partners living with HIV were encouraged to initiate ART as shortly every bit possible according to national guidelines. At the outset of the study, Art was available in public clinics to people living with HIV whose CD4 count was <350 cells/uL or with clinical indication. Partway through the study, national guidelines in each country were revised to encourage Fine art initiation for any individual living with HIV in an HIV serodiscordant relationship. Thus, at that bespeak, all partners living with HIV in this written report became Art eligible. Art was available to participants through public clinics and at the demonstration projection clinics. Participants living with HIV were evaluated for CD4 count and HIV RNA at study enrollment and at six-monthly intervals during follow up.
HIV-negative participants using PrEP were encouraged to discontinue PrEP in one case their study partner living with HIV used Art for at least six months (Effigy i). Results from HIV RNA testing were non required to guide counseling about PrEP use and potential viral suppression to reverberate the public delivery model in which HIV RNA testing was often unavailable. If available when PrEP discontinuation was considered, HIV RNA results could be used to identify the potential for non-adherence to ART; yet, testing was conducted on a six-monthly schedule timed to study showtime, not the ART initiation schedule, and testing may not have aligned with ART initiation. In lieu or requiring HIV RNA results, we adopted a conservative time of half-dozen months of Fine art utilise to obtain viral suppression based on data from HIV serodiscordant couples in clinical trials with carefully measured HIV RNA trajectories following Art initiationeleven. The arroyo of using a calendar catamenia since Fine art initiation is scalable in public clinics regardless of whether HIV RNA testing becomes more available.
Figure one. Strategy for PrEP delivery to HIV-negative persons with a partner known to be living with HIV.
This strategy of time-express PrEP use past the HIV-negative partner until the partner living with HIV sustained 6 months of Fine art employ was included in counseling discussions with couples beginning with study screening. In cases of Art non-adherence, new sexual partners with unknown HIV condition or Art utilize disclosed by the HIV-negative partner, or pregnancy intentions within the couple, counselors encouraged the HIV-negative partner to proceed PrEP.
PrEP adherence. We used medication consequence monitoring organization (MEMS) caps to tape all openings of PrEP pill bottles equally our primary measure of adherence and self-reported utilise and chemist's shop pill counts as additional measures of adherence; these were nerveless from all participants at all visits. Additionally, archived plasma from quarterly visits following PrEP dispensation was tested for quantification of tenofovir (TFV), the metabolized form of TDF, in a 15% random sample of participants. TFV levels were quantified using ultra-performance liquid chromatographic-tandem mass spectrometric (LC-MS/MS), with a limit of quantification of 0.31 ng/mL12.
Incident HIV infection. HIV-negative partners underwent HIV testing prior to PrEP dispensing at each follow-up visit, post-obit the national HIV rapid testing algorithms for Kenya and Uganda. Reactive results from rapid tests were confirmed with enzyme immunoassay (EIA) and HIV RNA quantification. For confirmed seroconverters, enrollment samples were quantified for HIV RNA; those positive for HIV RNA at enrollment were determined to have been infected prior to entry into the projection. Seroconverters with negative HIV RNA results from enrollment samples were adamant to have incident infections. For all seroconverters, archived plasma samples from the time point when seroconversion was detected underwent standard consensus sequencing of the pol region to detect HIV resistance. Additionally, for incident seroconversions, a sample from the study partner living with HIV was sequenced and sequences from both partners underwent phylogenetic assay and posterior probability of linkage with the apply of pairwise nucleotide distances betwixt sequences to determine whether the incident infection likely originated with the study partner.
Ethical statement
The written report protocol was canonical by the Human Subjects Division at the University of Washington (#STUDY00001674) and Ideals Review Committees overseeing each study site: Scientific Ethics Review Unit at the Kenya Medical Enquiry Institute (SSC No. 2441), the Ethics Review Commission of Kenyatta National Hospital (P286/05/2012), and the AIDS Enquiry Committee of the Uganda National Council of Science and Engineering (ARC 135 and ARC126). All participants provided written informed consent.
Statistical methods. Characteristics of couples and patterns of PrEP use were summarized using descriptive statistics. Methods for developing a counterfactual comparison accomplice accept been described previouslyvii. Briefly, we used data from the placebo arm of the prior Partners PrEP Study1, a PrEP clinical trial conducted from 2008–2011 among HIV serodiscordant couples in the same research clinics, to simulate a comparable "non-intervention" accomplice, frequency matched to the Partners Demonstration Project by HIV take a chance score and duration of study follow up. The hateful number of HIV infections expected in the counterfactual population was averaged over x,000 bootstrap samples and a 95% confidence interval was divers by the two.5th and 97.5thursday quantiles. The incidence rate ratio was computed comparing actual HIV incidence observed in the electric current report to the mean estimate from the counterfactual population; a 95% confidence interval was calculated using a Poisson distribution, and the p-value was estimated from the bootstrap distribution. Additional bootstrap distributions were constructed with restriction to the age and gender of the HIV-negative partner (one per gender) and enrollment plasma HIV RNA concentrations of the partner living with HIV, to create stratified estimates for these subgroups. All simulations excluded data from couples (n=3) whose HIV-infected partner was determined retrospectively to have been using ART at study enrollment. The bootstrap analyses and descriptive statistics were conducted using SAS version 9.iv (SAS Institute) and figures were generated using Powerpoint 2016 (Microsoft, USA) and Tableau 10.3 (Tableau Software, Seattle, U.s.a.).
Results
Participant characteristics. In total, 1694 couples were screened and 1013 enrolled between Nov 2012 and August 2014. Participant visits were conducted through June 2016 when all had been followed for 24 months. Main reasons for not beingness eligible to enroll included having a run a risk score <5, WHO stage >2 for the partner living with HIV, and abnormal renal values for the HIV-negative partner7. 3 couples were excluded from the analysis due to retrospectively ascertained utilise of Art at enrollment. At baseline, a substantial proportion of couples had characteristics that were consistent with having high risk for HIV manual: 41% of the partners living with HIV had plasma HIV RNA concentrations >50,000 copies/ml and 65% of couples reported condomless sexual activity in the prior month (Table 1). Two-thirds of couples had HIV-negative male person partners and 67% of these were not circumcised. Most couples were married (94%) and although the median time living together was 2.3 years (interquartile range [IQR] 0.8–6.3), very few couples had known their HIV discordant status more than a few months (median time known discordant 0.1 years, interquartile range [IQR] 0.1–0.3). Couples contributed a total of 1690.5 person-years of follow upwardly time. Retention was above 83% at all visits. 9 hundred eighty-two (97%) of HIV-negative participants initiated PrEP, including 960 (95%) that initiated at enrollment into the project. Amidst women, 96.6% initiated PrEP and among men, 98.five% initiated PrEP. The median duration of PrEP utilize was 12 months (IQR 6-18) and condomless sex was reported at 41.2% of visits when sex with the study partner was reported.
Table i. Characteristics of couples enrolled in the Partners Demonstration Projection.
| Characteristics of couples | N (%) or Median (IQR) |
|---|---|
| Total couples | 1010 |
| Married to each other | 954 (94%) |
| Years living together | 2.3 (0.eight, 6.iii) |
| Years enlightened of discordant condition | 0.i (0.one, 0.3) |
| Proportion without children | 570 (56%) |
| HIV take chances score* | 6 (6, eight) |
| Number of sexual activity acts between partners, prior month** | 5 (3, 10) |
| Any condomless sexual activity acts betwixt partners, prior calendar month** | 653 (65%) |
| Either partner had outside partners, prior month | 118 (12%) |
| Characteristics of HIV-negative partners | |
| Male gender | 677 (67%) |
| Age, years | 30 (26, 36) |
| Instruction, years | 8 (seven, 12) |
| Any monthly income | 868 (86%) |
| Circumcised, for male HIV-negative partners | 452 (67%) |
| Characteristics of partners living with HIV | |
| Male gender | 333 (33%) |
| Age, years | 28 (23, 35) |
| Education, years | 8 (vi, 11) |
| Any monthly income | 736 (73%) |
| CD4 cell count (cells/uL) | 436.0 (272.5, 638.0) |
| Viral load (logten copies/ml) | 4.6 (3.9, 5.0) |
| Viral load >50,000 copies/ml | 417 (41%) |
Patterns of PrEP use and discontinuation. Overall, 88.ane% of HIV-negative partners used PrEP until their partner living with HIV was using Art, including 51.three% who used PrEP for exactly 6 months post-obit Art initiation by their partner (Figure ii). PrEP utilize for >six months following Fine art initiation (past 114, 15.5% of PrEP users with at least 6 months of ART by the partner) was due to primarily to immediate fertility desires or current pregnancy (36.0% [41/114]), a want for longer ART apply by the partner living with HIV (fifteen% [17/114]), or unsuppressed virus (12% [14/114]). For HIV-negative partners who did not use PrEP (n=28), 89.3% had partners living with HIV who initiated Art. Merely 3 HIV-negative partners (0.3%) did not have protection from either PrEP or their partner's Fine art use during follow up. Among the 734 HIV-negative participants who discontinued PrEP, 35 (4.8%) re-started PrEP before the end of the 2-year follow upwards period due to reasons that included fertility desires (n=14), concerns virtually Art use and/or viral load in the partner living with HIV (n=5), resolution of an agin event (n=iv), and new sexual partnerships (n=3).
Figure two. PrEP Employ and Discontinuation by HIV-negative individuals with partners known to be living with HIV.
During the follow up menstruation prior to the partner living with HIV having used Fine art for six months (comprising 928.ii person-years), HIV-negative partners were dispensed PrEP for 602.4 person-years (64.9%, Figure 3, orange sections). When PrEP was not dispensed (Figure 3, green sections), 46.6% included time when no sex with the study partner living with HIV was reported. Of the remaining time without PrEP, 26.i% of time without PrEP was due to a protocol-defined effect (pregnancy, abnormal serum creatinine measurement, etc.) and 24.8% was due to participant decision. For 129.six person-years (fourteen.0% of all study time), participants missed written report visits and were unable to be offered PrEP.
Effigy 3. PrEP use past HIV-negative partners from the time of study enrollment through 6 months of ART use by HIV infected partners.
PrEP adherence. Amidst 140 participants randomly selected for TFV quantification at 607 visits following PrEP dispensation, 81% of samples had TFV detected (81% from women and 81% from men). MEMS data also were consistent with high adherence: 71% (72% from women and 68% from men) of visits had ≥80% of expected doses taken since the prior visit and 85% (84% from women and 85% from men) had ≥fifty% taken. Based on pharmacy pill counts, 87% (86% of women and 87% of men) and 96% (95% of women and 97% of men) of bottles had ≥lxxx% and ≥50% of expected doses taken, respectively.
HIV incidence and intervention effectiveness. In that location were 18 seroconversions, including 4 incident seroconversions and fourteen determined to have been infected at enrollment. Based on the iv incident seroconversions, the observed incidence rate was 0.24 per 100 person-years (Table 2). Using bootstrapping methods with the placebo arm of the Partners PrEP Study, we estimated that 80.7 incident infections were expected in the absence of our intervention, resulting in an estimated incidence of 4.75 per 100 person-years. The incidence rate ratio was 0.05 (95% confidence interval [CI] 0=0.02-0.14) for an intervention effectiveness of 95% (95% CI: 86-98%). The intervention was highly effective in all subgroups examined including women (effectiveness=93%, p<0.0001), HIV-negative partners aged <25 (effectiveness=94%, p<0.0001), and among couples with HIV positive partners having HIV RNA ≥fifty,000 copies/ml at baseline (effectiveness=95%, p<0.0001).
Table 2. Expected versus observed HIV incidence.
| Expectation from Partners PrEP Study* | Observed from Partners Sit-in Project | Incidence charge per unit ratio (95% CI) p-value | Effectiveness (95% CI) | |||
|---|---|---|---|---|---|---|
| Northward incident infections/ N years follow up | Incidence** | Due north incident infections/ Northward years follow up | Incidence** | |||
| Overall incidence | lxxx.7/1700.2 | iv.75 | iv/1682.iii | 0.24 | 0.05 (0.02, 0.xiv) p<0.0001 | 95% (86–98%) |
| By gender | ||||||
| Women | 42.0/553.0 | vii.60 | 3/560.4 | 0.54 | 0.07 (0.02, 0.23) p<0.0001 | 93% (77–98%) |
| Men | 41.i/1144.6 | iii.59 | one/1121.9 | 0.09 | 0.03 (0.00, 0.18) p<0.0001 | 97% (82–100%) |
| Past historic period category | ||||||
| HIV-negative partner <25 years old | 17.1/344.7 | 4.97 | 1/332.0 | 0.30 | 0.06 (0.01, 0.46) p<0.0001 | 94% (54–99%) |
| HIV-negative partner ≥25 years old | 62.7/1357.four | 4.62 | iii/1350.three | 0.22 | 0.05 (0.02, 0.fifteen) p<0.0001 | 95% (85–98%) |
| By HIV RNA category | ||||||
| HIV-positive partner HIV RNA ≥50,000 copies/ml | 39.3/674.0 | 5.84 | 2/707.iii | 0.28 | 0.05 (0.01, 0.twenty) p<0.0001 | 95% (lxxx–99%) |
| HIV-positive partner HIV RNA <50,000 copies/ml | 41.4/1024.9 | 4.04 | 2/975.0 | 0.21 | 0.05 (0.01, 0.21) p<0.0001 | 95% (79–99%) |
Of the iv individuals with incident HIV infection, none had TFV detected in plasma samples. The partners of three of these individuals were virally suppressed at the time when HIV was detected in the initially HIV-negative partner, and all initially HIV-negative partners reported other sexual partners in addition to their study partner. Thus, partners who were not enrolled in the study (i.e., new or additional partners, whose HIV serostatus was unknown to the study) likely transmitted these infections. For the private with incident HIV infection whose study partner had quantifiable HIV RNA when HIV was detected, analysis of the politician gene sequences from both partners revealed a probable linkage betwixt two sequences. For this woman, her male partner had not yet initiated ART, as his CD4 count of 515 cells/mm3 did non qualify for initiation during the fourth dimension when Ugandan Art guidelines required CD4 <350 cells/mL. None of the 4 people with incident infection had mutations conferring resistance to TDF or FTC. Vv of the fourteen participants determined to accept been infected with HIV at enrollment had an M184V mutation consistent with resistance to FTC.
HIV protection at report end. After ii years of follow up, 75.4% of couples had a partner living with HIV whose viral load was documented as suppressed and 8.5% had Fine art use past the partner living with HIV simply did not have viral suppression or had unknown viral load levels (Figure 4). For iv.half dozen% of couples (n=46 couples), ART was not being used by the partner living with HIV, including 20 couples who reported sex together in the past 3 months (15 with 100% condom utilize and 5 with some condomless sex).
Effigy 4. ART status within each couple at the end of the report follow-up.
Discussion
In this open-label evaluation of PrEP for HIV-negative partners within HIV serodiscordant couples, PrEP uptake and adherence were loftier and incident HIV was virtually eliminated. For 1010 HIV-negative persons followed for 2 years, PrEP was dispensed for 12 months on average. Since the first of our evaluation, ART guidelines have become more than inclusive and ART use is more than standard for all people living with HIV. These changes are likely to result in a shorter average duration of PrEP use since the time between HIV diagnosis and ART initiation and viral suppression is likely shorter for partners living with HIV. When PrEP was non used, a bulk of people had HIV protection by their partner'southward ART use and viral suppression or had dissolved their partnership with their partner known to be living with HIV.
Our model of PrEP delivery was to introduce PrEP into couples-based HIV prevention and to recommend PrEP discontinuation once the partner living with HIV initiated and sustained ART. Almost all of the HIV-negative partners initiated PrEP and afterwards 2 years of follow up, 75% of couples could rely on ART use and viral suppression in the partner living with HIV for protection against HIV manual. Throughout the ii-yr follow upward menses, about half of the HIV-negative participants followed the PrEP strategy equally our protocol intended, with PrEP used until their partner living with HIV had used ART for half-dozen months. Others used PrEP for longer or shorter periods overlapping with Art. These metrics demonstrate the feasibility for potentially implementing this strategy in East Africa as well as the ability to integrate PrEP into an existing clinical structure.
When PrEP was dispensed, adherence was moderate to loftier affording early on protection from HIV acquisition and establishing a sustainable adherence behavior. Demonstration projects have shown greater adherence to PrEP than was observed in the clinical trials, potentially due to messages clearly describing the efficacy of PrEP and because they are ofttimes implemented in public clinics, which are more familiar than clinical trial settings. Importantly, adherence appears to align with HIV risk. Incident HIV infections occurred in our written report in the absence of PrEP use and primarily outside of the written report partnerships. These instances highlight opportunities to aggrandize PrEP messaging to comprise risk inside newly forming relationships and with coincidental partners or transactional partners. For immature people, specially those who are not yet married, letters need to be realistic and recognize the dynamic nature of relationships in guild to encourage open communication with counselors and counseling grounded in realistic prevention strategies.
This intervention gave HIV-negative persons with partners living with HIV a means for engaging with healthcare and a primary prevention strategy. By engaging every bit couples, the partner living with HIV gained familiarity with clinical care and antiretroviral use, enhancing their cognition of Art programs with customer trust and abilities to initiate Art faster13. This integrated approach provides back up to each partner within the couple also equally the couple as a unit. Without PrEP, the HIV-negative partner has to rely merely on safe use for master prevention until the eventual identification of HIV, Art initiation, and sustained ART use with viral suppression. Condom utilise within marriage has been reported to be hard due to cultural norms that discourage condom use within union, desires for pregnancy, and difficulties internalizing and coping with discordancy14.
Additional benefits of this intervention include improved relationship stability and strengthening advice and negotiation skills between couples that have been reported elsewhere15,16. These benefits foster opportunities for couples to discuss their sexual behavior, plans for pregnancy, concerns well-nigh HIV risk, and other topics that are sensitive but important for reducing HIV chance17. By designing this study under an implementation scientific discipline framework, we had an opportunity to refine standardized letters for couples about biomedical HIV prevention and airplane pilot improver components that would increase efficiencies in intervention delivery, such as HIV self-testing, less frequent monitoring of kidney part, and adherence support through text letters10,18–20.
Within this study, microcosting assay suggests cost-effectiveness, with the largest portion of costs owing to purchasing medication and laboratory monitoring21. Virtually PrEP users in this projection needed PrEP for a limited fourth dimension until ART utilise and viral suppression could be the master mode of HIV protection. This aspect contributes to the toll-effectiveness of this delivery strategy but does not fully account for the frequency of re-starting PrEP during follow up beyond ii years. Time to come evaluations within sustainable commitment programs will provide estimates of how frequently PrEP is re-started and the toll implications. As PrEP delivery programs are scaled up, identifying opportunities to improve efficiency from the patient and provider perspectives volition reduce costs and potentially raise effectiveness.
We measured adherence with MEMS caps and laboratory markers that are enquiry tools and unlikely suitable for public clinics given their cost and logistical requirements (aircraft samples to the U.s.a./key laboratory, provision of MEMs to each participant, etc.). However, programmatic calibration up of HIV viral load testing is existence implemented and tin be used to guide counseling nigh Art adherence and prevention of transmission and to reinforce messages nigh PrEP adherence when viral load is not suppressed. In addition, we provided participants with a small reimbursement as a token of appreciation for their participation in inquiry procedures and nosotros cannot tease apart the caste to which this influenced participant retention in the project. A final limitation is that our model does non consider additional HIV take chances factors, such as the frequency of condomless sex. During follow up, couples in the Partners Sit-in Project reported condomless sexual practice more than frequently than those in the comparing study and thus this group is likely to have higher risk.
PrEP delivery to HIV-negative individuals with partners known to exist living with HIV was highly effective. HIV-negative participants used PrEP and almost discontinued in parallel with sustained Art use past their partner living with HIV, transferring their HIV protection to their partner's Art use. Offering PrEP as a feature of existing ART programs must exist washed via messages and materials that are tailored for couples in club to reach members of HIV serodiscordant couples. While multiple venues for PrEP provision are likely needed in gild to tailor services to different subpopulations, providing PrEP through Art clinics takes advantage of existing infrastructure, has benefits for both partners within HIV serodiscordant couples, and is feasible to gyre out on a national level.
Data availability
Data are available upon request to the authors' inquiry centre, by emailing [email protected] with a concept sail stating the objectives of the analysis and variables desired.
Competing interests
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Electric current Reviewer Status: Primal to Reviewer Statuses VIEW HIDE ApprovedThe newspaper is scientifically audio in its electric current course and only small, if whatever, improvements are suggested Approved with reservations A number of pocket-size changes, sometimes more than meaning revisions are required to address specific details and ameliorate the papers bookish merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version two
VERSION ii
PUBLISHED 30 January 2018 Revised
Reviewer Report31 January 2018
George W. Rutherford , Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA
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PUBLISHED 06 Nov 2017
Reviewer Report04 Dec 2017
John Idoko , National Agency for the Control of AIDS, Abuja, Nigeria Morenike Ukpong , College of Health, Obafemi Awolowo University, Ile-Ife, Nigeria
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Reviewer Report29 Nov 2017
George W. Rutherford , Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, U.s.a.
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