Continuation of Reversible Contraception Following Enrollment in the Zika Contraception Access Network (Z-CAN) in Puerto Rico, 2016-2020.

The Zika Contraception Access Network (Z-CAN) provided access to high-quality client-centered contraceptive services across Puerto Rico during the 2016-2017 Zika virus outbreak. We sent online surveys during May 2017-August 2020 to a subset of Z-CAN patients at 6, 24, and 36 months after program enrollment (response rates: 55-60 percent). We described contraceptive method continuation, method satisfaction, and method switching, and we identified characteristics associated with discontinuation using multivariable logistic regression. Across all contraceptive methods, continuation was 82.5 percent, 64.2 percent, and 49.9 percent at 6, 24, and 36 months, respectively. Among continuing users, method satisfaction was approximately ≥90 percent. Characteristics associated with decreased likelihood of discontinuation included: using an intrauterine device or implant compared with a nonlong-acting reversible contraceptive method (shot, pills, ring, patch, or condoms alone); wanting to prevent pregnancy at follow-up; and receiving as their baseline method the same method primarily used before Z-CAN. Other associated characteristics included: receiving the method they were most interested in postcounseling (6 and 24 months) and being very satisfied with Z-CAN services at the initial visit (6 months). Among those wanting to prevent pregnancy at follow-up, about half reported switching to another method. Ongoing access to contraceptive services is essential for promoting reproductive autonomy, including supporting patients with continued use, method switching, or discontinuation.

Motivations to use hormonal contraceptive methods and condoms among HIV-positive and negative women randomized to a progestin contraceptive in Malawi: a qualitative study.

BACKGROUND: Although many countries have been promoting hormonal contraceptives to prevent unintended pregnancy and condom use to prevent HIV transmission, little is known about how women targeted by these messages have interpreted and internalized them. We describe HIV-positive and negative women's understanding of the benefits of contraception and condoms and their motivations to use them. METHODS: This is a qualitative sub-study from a clinical trial evaluating the effects of progestin contraception on HIV-positive and negative women aged 18-45 years randomly assigned to depot medroxyprogesterone acetate (DMPA) injection or levonorgestrel (LNG) implant. We purposively recruited 41 women to participate in in-depth interviews (IDIs) and focus group discussions (FGDs) after randomization into the main study. We conducted a total of 30 IDIs and 6 FGDs comprised of 4-7 women (N = 32). All women were counselled about potential risks for HIV acquisition/transmission with progestin-only contraception, drug-drug interactions between the implant and efavirenz-based ART, and the need to use condoms with their assigned contraceptive to help prevent pregnancy and HIV acquisition and transmission. RESULTS: All women understood that HIV is transmitted through unprotected sex and that HIV transmission can be prevented through condom use but not DMPA injection or LNG implant use. Nearly all HIV-positive women knew or suspected that their partners were also HIV-positive and were most interested in using condoms to prevent infection with a drug-resistant HIV strain to keep their HIV viral load low. Almost all reported that their partners agreed to condom use, but few used them consistently. Most women believed that condoms were effective at preventing both HIV and pregnancy if used consistently. Nearly all women considered contraception and condom use as important in preventing unintended pregnancy and HIV because partner disclosure of HIV status is low. CONCLUSION: Our results showed that both HIV-positive and negative women understood modes of HIV transmission and prevention and were aware that hormonal contraceptives are only effective for preventing pregnancy and not HIV. Although both HIV-negative and positive women were motivated to use condoms to prevent both HIV acquisition and infection with other HIV strains respectively, they all faced challenges from their partners in using condoms consistently.

Women's perspectives on relationship dynamics with their partners and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use.

Background: Limited information exists about relationship dynamics and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use among women in Malawi.Methods: Ninety-seven women aged 18-45 years were randomly assigned to initiate the depot medroxyprogesterone acetate injectable or levonorgestrel implant from May 2014 to April 2015 in Lilongwe, Malawi. Women were recruited after randomisation to participate in semi-structured interviews about HIV and family planning using purposive sampling. Interviews were thematically analysed using within and between group comparisons.Results: We conducted individual interviews and/or focus group discussions with 41 women: 30 (73%) women living with HIV and 11 (27%) women not living with HIV. Most women living with HIV who participated in in-depth interviews disclosed their status to their partners, and most partners agreed to get HIV tested only after disclosure. Nearly all women said their partners agreed to use condoms, but few used them consistently. Nearly all women believed their current and former partners had outside partners. Most women living with HIV who participated in in-depth interviews believed their current or other serious partners were the source of their infection. Some women thought their partner's infidelity was due to their partner's disinterest in sex with them during menstrual/ breakthrough bleeding. Some women included their partners in contraceptive decision-making when the partner was supportive.Discussion: Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study. All women reported challenges with consistent condom use with their male partners, although contraceptive use was generally more acceptable. Women included their partners in their decision-making concerning contraceptive use when they were supportive.

Contraception as a Medical Countermeasure to Reduce Adverse Outcomes Associated With Zika Virus Infection in Puerto Rico: The Zika Contraception Access Network Program.

The Zika Contraception Access Network established a network of 153 physicians across Puerto Rico as a short-term emergency response during the 2016-2017 Zika virus outbreak to provide client-centered contraceptive counseling and same-day contraception services at no cost for women who chose to prevent pregnancy. Between May 2016 and August 2017, 21 124 women received services. Contraception was used as a medical countermeasure to reduce adverse Zika-related reproductive outcomes during the outbreak and may be considered a key strategy in other emergencies.

Contraceptive Use Among Women at Risk for Unintended Pregnancy in the Context of Public Health Emergencies - United States, 2016.

Ensuring access to and promoting use of effective contraception have been identified as important strategies for preventing unintended pregnancy (1). The importance of ensuring resources to prevent unintended pregnancy in the context of public health emergencies was highlighted during the 2016 Zika virus outbreak when Zika virus infection during pregnancy was identified as a cause of serious birth defects (2). Accordingly, CDC outlined strategies for state, local, and territorial jurisdictions to consider implementing to ensure access to contraception (3). To update previously published contraceptive use estimates* among women at risk for unintended pregnancy† and to estimate the number of women with ongoing or potential need for contraceptive services,§,¶ data on contraceptive use were collected during September-December 2016 through the Behavioral Risk Factor Surveillance System (BRFSS). Results from 21 jurisdictions indicated that most women aged 18-49 years were at risk for unintended pregnancy (range across jurisdictions = 57.4%-76.8%). Estimates of the number of women with ongoing or potential need for contraceptive services ranged from 368 to 617 per 1,000 women aged 18-49 years. The percentage of women at risk for unintended pregnancy using a most or moderately effective contraceptive method** ranged from 26.1% to 65.7%. Jurisdictions can use this information to estimate the number of women who might seek contraceptive services and to plan and evaluate efforts to increase contraceptive use. This information is particularly important in the context of public health emergencies, such as the recent Zika virus outbreak, which have been associated with increased risk for adverse maternal-infant outcomes (2,4-6) and have highlighted the importance of providing women and their partners with resources to prevent unintended pregnancy.

Perceptions of the Zika Virus, Contraceptive Access, and Motivation to Participate in the Zika Contraception Access Network Program: Qualitative Analysis of Focusgroup Discussions with Puerto Rican Women.

OBJECTIVE: During the 2016-2017 Zika virus outbreak in Puerto Rico, the Zika Contraception Access Network (Z-CAN) provided client-centered contraceptive counseling and access to the full range of reversible contraceptive methods at no cost to prevent unintended pregnancies and thereby to reduce Zika-related birth outcomes. METHODS: To understand how Puerto Rican women's perceptions of the Zika virus affected contraceptive decisions and assess how they heard about the Z-CAN program and what influenced their participation, or lack thereof, 24 focus-group discussions were conducted among women of reproductive age who did and did not participate in Z-CAN. RESULTS: Women who participated in the discussions often had heard about Z-CAN from their physician or friends; non-participants had heard about Z-CAN from Facebook or friends. Women expressed satisfaction on finding a Z-CAN clinic and valued the same-day provision of contraceptives. When a preferred contraceptive method or a first appointment was not readily available, women reconsidered accessing the program. Women's perceptions and trust of reproductive healthcare providers, their engagement in social networks, and their ability to choose a contraceptive method that best meets their needs can influence participation in contraception-access programs. CONCLUSION: Focus groups can be used to understand women's knowledge of the Zika virus, barriers and facilitators to contraception access, and motivations for participation in the Z-CAN program.

Long-acting reversible contraception use and unmet desire among patients after the Zika Contraception Access Network Program in Puerto Rico.

OBJECTIVES: To describe unmet desire for long-acting reversible contraception (LARC) after the Zika Contraception Access Network (Z-CAN) in Puerto Rico during the 2016-2017 Zika outbreak. STUDY DESIGN: Z-CAN patients completed surveys about contraception experiences over a 3-year period. RESULTS: Of 1809 respondents, 3% never used LARC but reported wanting it since their initial visit. As reasons for not getting LARC, nearly 50% indicated a provider-related reason and 25% reported cost. CONCLUSIONS: Few Z-CAN patients who never used LARC had unmet desire. Provider training in contraception guidelines and strategies to address costs can expand access to the full range of reversible contraception. IMPLICATIONS: Three years after a short-term program provided reversible contraception in Puerto Rico, few respondents had never used but wanted a long-acting reversible contraception method. Nearly half reported provider-related reasons for not receiving long-acting reversible contraception, and 25% reported cost. Provider awareness of contraceptive guidance and method availability can support client-centered care.

Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial.

In a microbicide safety and effectiveness trial (HPTN 035) in Malawi, 585 women completed the same questionnaire through a face-to-face interview (FTFI) and an audio computer-assisted self-interview (ACASI). Concordance between FTFI and ACASI responses ranged from 72.0 % for frequency of sex in the past week to 95.2 % for anal intercourse (AI) in the past 3 months. Reported gel and condom use at last sex act were marginally lower with ACASI than FTFI (73.5 % vs. 77.2 %, p = 0.11 and 60.9 % vs. 65.5 %, p = 0.05, respectively). More women reported AI with ACASI than FTFI (5.0 % vs. 0.2 %, p < 0.001). Analyses of consistency of responses within ACASI revealed that 15.0 % of participants in the condom-only arm and 28.7 % in the gel arm provided at least one discrepant answer regarding total sex acts and sex acts where condom and gel were used (19.2 % reported one inconsistent answer, 8.1 % reported two inconsistent answers, and 1.4 % reported three inconsistent answers). While ACASI may provide more accurate assessments of sensitive behaviors in HIV prevention trials, it also results in a high level of internally inconsistent responses.

Provider Perceptions of Facilitators of and Barriers to Implementation of the Zika Contraception Access Network: A Qualitative Evaluation.

OBJECTIVE: From May 2016 through September 2017, the Zika Contraception Access Network (Z-CAN) program increased access to contraception during the Zika virus outbreak in Puerto Rico by providing no-cost client-centered contraceptive counseling and (same-day) access to the full range of US Food and Drug Administration-approved reversible contraceptives to women desirous of not becoming pregnant. The purpose of this study was to identify areas for programmatic improvement and enhance the sustainability of services from the perspectives of participating Z-CAN physicians and other staff. METHODS: From April through July 2017, 49 in-depth key-informant interviews were conducted with Z-CAN physicians and clinic staff. Twenty-five clinics participating in the Z-CAN program were selected through a cluster randomization process. A semi-structured interview guide was developed to explore the participants' perceptions of the Z-CAN program and examine facilitators of and barriers to said implementation. A thematic analysis of the emerging topics was conducted. RESULTS: Our analysis encountered 4 common overarching themes: facilitators of the Z-CAN program; barriers to Z-CAN implementation; the perceived impact of Z-CAN on providers and communities; and the sustainability of contraception access after the Z-CAN program ended. The key findings were that provider training, mentor support, and communication campaigns facilitated program implementation and that delays in the acquisition and distribution of contraceptives were obstacles. CONCLUSION: Lessons learned from the implementation of Z-CAN from the perspective of physicians and other staff can be used to work towards sustainable contraceptive services in Puerto Rico and inform other contraception-access programs' design and implementation strategies.

Vaginal microbiome, antiretroviral concentrations, and HIV genital shedding in the setting of hormonal contraception initiation in Malawi.

OBJECTIVE: The aim of this study was to understand how vaginal microbiota composition affects antiretroviral concentrations in the setting of hormonal contraception initiation. METHODS: Cervicovaginal fluid (CVF) concentrations of tenofovir, lamivudine, and efavirenz from 73 Malawian women with HIV were compared before and after initiation of depot-medroxyprogesterone acetate (DMPA) or levonorgestrel implant. We evaluated antiretroviral concentrations and vaginal microbiota composition/structure in the context of contraception initiation and predicted genital shedding using multivariable repeated measurements models fit by generalized estimating equations. RESULTS: Mean lamivudine CVF concentrations decreased 37% 1 month after contraception initiation. Subgroup analyses revealed a 41% decrease in women 1 month after initiating levonorgestrel implant, but no significant difference was observed in DMPA group alone. Tenofovir, lamivudine, and efavirenz CVF concentrations were positively correlated with anaerobic bacteria associated with nonoptimal vaginal microbiota. Risk of genital HIV shedding was not significantly associated with tenofovir or lamivudine CVF concentrations [tenofovir relative risk (RR): 0.098, P = 0.75; lamivudine RR: 0.142, P = 0.54]. Lack of association between genital HIV shedding and efavirenz CVF concentrations did not change when adjusting for vaginal microbiota composition and lamivudine/tenofovir CVF concentrations (RR: 1.33, P = 0.531). CONCLUSION: No effect of hormone initiation on genital shedding provides confidence that women with HIV on either DMPA or levonorgestrel implant contraception will not have compromised ART efficacy. The unexpected positive correlation between antiretroviral CVF concentrations and certain bacterial taxa relative abundance requires further work to understand the mechanism and clinical relevance.

Economic evaluation of Zika Contraception Access Network in Puerto Rico during the 2016-17 Zika virus outbreak.

OBJECTIVE: During the 2016-2017 Zika virus (ZIKV) outbreak, the prevention of unintended pregnancies was identified as a primary strategy to prevent birth defects. This study estimated the cost-effectiveness of the Zika Contraception Access Network (Z-CAN), an emergency response intervention that provided women in Puerto Rico with access to the full range of reversible contraception at no cost and compared results with a preimplementation hypothetical cost-effectiveness analysis (CEA). STUDY DESIGN: We evaluated costs and outcomes of Z-CAN from a health sector perspective compared to no intervention using a decision tree model. Number of people served, contraception methods mix, and costs under Z-CAN were from actual program data and other input parameters were from the literature. Health outcome measures included the number of Zika-associated microcephaly (ZAM) cases and unintended pregnancies. The economic benefits of the Z-CAN intervention were ZIKV-associated direct costs avoided, including lifetime medical and supportive costs associated with ZAM cases, costs of monitoring ZIKV-exposed pregnancies and infants born from Zika-virus infected mothers, and the costs of unintended pregnancies prevented during the outbreak as a result of increased contraception use through the Z-CAN intervention. RESULTS: The Z-CAN intervention cost a total of $26.1 million, including costs for the full range of reversible contraceptive methods, contraception related services, and programmatic activities. The program is estimated to have prevented 85% of cases of estimated ZAM cases and unintended pregnancies in the absence of Z-CAN. The intervention cost was projected to have been more than offset by $79.9 million in ZIKV-associated costs avoided, 96% of which were lifetime ZAM-associated costs, as well as $137.0 million from avoided unintended pregnancies, with total net savings in one year of $216.9 million. The results were consistent with the previous CEA study. CONCLUSION: Z-CAN was likely cost-saving in the context of a public health emergency response setting.

Strategies and safeguards to ensure access to long-acting reversible contraception removal after the Zika Contraception Access Network ended: A prospective analysis of patient reported complaints.

OBJECTIVE: The Zika Contraception Access Network (Z-CAN) was a short-term emergency response intervention that used contraception to prevent unintended pregnancy to reduce Zika-related adverse birth outcomes during the 2016 2017 Zika virus outbreak in Puerto Rico. Strategies and safeguards were developed to ensure women who chose long-acting reversible contraception (LARC) had access to no-cost removal, if desired, after Z-CAN ended. STUDY DESIGN: We assessed the number of women who chose LARC at their initial Z-CAN visit who filed complaints regarding challenges with LARC removal within 30-months after the Z-CAN program ended. Complaints and program responses were categorized. RESULTS: Of the 29,221 women who received Z-CAN services, 20,381 chose a LARC method at their initial visit (IUD = 12,276 and implant = 8105). Between September 2017 and February 2020, 63 patient complaints were logged, mostly due to LARC removal charges (76.2%) which were generally (71.4%) determined to be inappropriate charges. All complaints filed were resolved allowing LARC removal within an average of 28 days. CONCLUSION: Safeguards to ensure prompt LARC removal when desired are critical to ensure women s reproductive autonomy. IMPLICATIONS: Strategies and safeguards used by Z-CAN to ensure women have access to LARC removal might be used by other contraception programs to prevent reproductive coercion and promote reproductive autonomy to best meet the reproductive needs of women.

Effect of efavirenz on levonorgestrel concentrations among Malawian levonorgestrel implant users for up to 30 months of concomitant use: a subanalysis of a randomized clinical trial.

OBJECTIVES: Our primary objective was to compare geometric mean levonorgestrel concentrations between levonorgestrel implant users who were or were not taking the antiretroviral efavirenz, for up to 30 months after implant initiation. Our secondary objective was to evaluate the pregnancy rate among levonorgestrel implant users on efavirenz. STUDY DESIGN: We performed a subanalysis of 42 Malawian women randomized to initiate the levonorgestrel implant as part of a parent randomized clinical trial. Our subset included 30 HIV-infected women taking efavirenz and 12 HIV-uninfected women not taking efavirenz. They underwent urine pregnancy testing every 3 months and serum levonorgestrel testing at day 3 and months 1, 3, 6, 12, 18, 24, 27 and 30 after implant initiation. Geometric mean levonorgestrel concentrations were calculated for efavirenz users and non-efavirenz users at each time point. RESULTS: The geometric mean levonorgestrel concentrations were lower for efavirenz users than non-efavirenz users at every time point; the geometric mean ratio for efavirenz users:non-efavirenz users ranged from 0.60 [90% confidence interval (CI) 0.46-0.79] at 1 month to 0.27 (90% CI 0.12-0.61) at 30 months after implant insertion. No pregnancies occurred over 60 woman-years of concomitant levonorgestrel implant and efavirenz use, although 11 women had levonorgestrel concentrations < 180 pg/mL (the previously suggested minimum threshold concentration for efficacy). CONCLUSIONS: Efavirenz users had lower levonorgestrel concentrations than non-efavirenz users, and one third of our concomitant efavirenz and levonorgestrel implant users had concentrations < 180 pg/mL. Continued evaluation of the contraceptive efficacy of the levonorgestrel implant may be needed for efavirenz users. IMPLICATIONS: Among 42 Malawian women using the levonorgestrel implant for contraception, women who were taking the antiretroviral efavirenz had lower serum levonorgestrel concentrations than women who were not taking efavirenz. However, none of the women who were taking efavirenz became pregnant over 60 women-years of follow-up.

Endogenous Hormones and Antiretroviral Exposure in Plasma, Cervicovaginal Fluid, and Upper-Layer Packed Cells of Malawian Women Living with HIV.

Overlap in metabolism pathways of endogenous female sex hormones and antiretroviral drugs may lead to altered exposure to these compounds. In a family planning clinic in Lilongwe, Malawi, blood, blood cell, and cervicovaginal fluid (CVF) samples from seventy-three HIV positive Malawian women taken in follicular and luteal menstrual phases were assessed for estradiol and progesterone by chemiluminescent immunoassay, and for antiretroviral concentration by liquid chromatography-mass spectrometry. In both follicular and luteal phases, estradiol concentrations were lower in women receiving efavirenz compared with women on non-efavirenz regimens or no antiretroviral therapy (p < .01). Serum estradiol was moderately and negatively correlated with efavirenz plasma (r = -0.36, p < .001) and CVF (r = -0.50, p < .001) concentrations. Serum estradiol was a significant predictor of efavirenz CVF concentrations even after adjusting for efavirenz plasma concentrations (p = .02). In upper-layer packed cells (ULPCs), tenofovir diphosphate (TFVdp) concentrations were similar between follicular and luteal phases and were not correlated with estradiol or progesterone concentrations. Tenofovir concentrations in CVF were not associated with menstrual cycle or serum hormone concentrations. In CVF and plasma, efavirenz concentrations were negatively correlated with serum estradiol concentrations, suggesting a modulatory effect of estradiol on efavirenz metabolism and/or transport processes, and/or an effect of efavirenz on the metabolism of estradiol. Differences in CVF persisted even after adjusting for plasma concentrations, suggesting a mechanism specific to the female genital compartment separate from absorption or hepatic metabolism. In contrast, TFVdp concentrations in ULPC were not influenced by endogenous estradiol or progesterone concentrations.

Final Program Data and Factors Associated With Long-Acting Reversible Contraception Removal: The Zika Contraception Access Network.

OBJECTIVE: To describe characteristics of the full population of women who participated in the Zika Contraception Access Network program in Puerto Rico during the virus outbreak and to examine factors associated with removal of a long-acting reversible contraception (LARC) method by a Zika Contraception Access Network provider during the program's duration (May 2016-September 2017). METHODS: We conducted an observational cohort study. The Zika Contraception Access Network program was designed to increase access to contraception services in Puerto Rico for women who chose to prevent pregnancy during the Zika virus outbreak as a primary strategy to reduce adverse Zika virus-related pregnancy and birth outcomes. Among program participants, an observational cohort of women served by the Zika Contraception Access Network Program, we describe their demographic and program-specific characteristics, including contraceptive method mix before and after the program. We also report on LARC removals by Zika Contraception Access Network providers during the program. We examined factors associated with LARC removal using multivariable logistic regression. RESULTS: A total of 29,221 women received an initial Zika Contraception Access Network visit during the program. Ninety-six percent (27,985) of women received same-day provision of a contraceptive method and 70% (20,381) chose a LARC method. While the program was active, 719 (4%) women who chose a LARC at the initial visit had it removed. Women with a college degree or higher were more likely to have their LARC removed (adjusted prevalence ratio [aPR] 1.24); breastfeeding women (aPR 0.67) and those using a LARC method before Zika Contraception Access Network (aPR 0.55) were less likely to have their LARC removed. CONCLUSION: The Zika Contraception Access Network program was designed as a short-term response for rapid implementation of contraceptive services in a complex emergency setting in Puerto Rico and served more than 29,000 women. The Zika Contraception Access Network program had high LARC uptake and a low proportion of removals by a Zika Contraception Access Network provider during the program. A removal-inclusive design, with access to removals well beyond the program period, maximizes women's reproductive autonomy to access LARC removal when desired. This model could be replicated in other settings where the goal is to increase contraception access.

Physician and clinic staff attitudes and practices during implementation of the Zika Contraception Access Network.

OBJECTIVE: The Zika Contraception Access Network (Z-CAN) provided women in Puerto Rico access to contraceptive counseling and the full range of reversible contraceptive methods, on the same day and at no cost, during the Zika virus outbreak. Because trained physicians and clinic staff were crucial to the program, we aimed to assess the implementation of and satisfaction with Z-CAN from their perspectives. STUDY DESIGN: Physicians and clinic staff in the Z-CAN program participated in an online survey on program implementation (e.g., on-site and same-day contraceptive provision), program satisfaction, and knowledge consistent with program training (e.g., contraceptive initiation and safety, client-centered contraceptive counseling, intrauterine device [IUD] and implant insertion and removal). RESULTS: Survey respondents included 63 physicians and 53 clinic staff members. A high proportion of physicians (>93%) reported providing IUDs, implants, pills, rings, condoms, and injections and most were very often or always able to provide same-day access to most methods. Over 90% of physicians were satisfied with the Z-CAN program, training, and ongoing support. Staff satisfaction with these program elements was similar but slightly lower. Knowledge about exams and tests needed for initiation and safety of methods varied but was generally consistent with guidelines on which physicians received training. Most physicians (>90%) reported confidence in skills on which they received training as part of the program. CONCLUSIONS: From the perspectives of participating physicians and clinic staff, the program was generally implemented as intended and providers were largely satisfied with program strategies including training and on-going support. IMPLICATIONS: Certain key components of the Z-CAN program, such as training, proctoring, and involvement of clinic staff were likely critical to Z-CAN's implementation and provider satisfaction. Results from this provider survey can inform implementation of similar efforts to increase access to contraception in both emergency and non-emergency settings.

Program Fidelity and Patient Satisfaction among Women Served by the Zika Contraception Access Network Program in Puerto Rico.

BACKGROUND: The Zika Contraception Access Network (Z-CAN) was designed to provide women in Puerto Rico who chose to delay or avoid pregnancy during the 2016-2017 Zika virus outbreak access to high-quality client-centered contraceptive counseling and the full range of reversible contractive methods on the same day and at no cost through a network of trained providers. We evaluated the implementation of Z-CAN from the patient perspective. METHODS: An online survey, administered to a subset of women served by the Z-CAN program approximately 2 weeks after their initial Z-CAN visit, assessed patient satisfaction and receipt of services consistent with select program strategies: receipt of high-quality client-centered contraceptive counseling, same-day access to the contraceptive method they were most interested in after counseling, and no-cost contraception. RESULTS: Of 3,503 respondents, 85.2% reported receiving high-quality client-centered contraceptive counseling. Among women interested in a contraceptive method after counseling (n = 3,470), most reported same-day access to that method (86.8%) and most reported receiving some method of contraception at no cost (87.4%). Women who reported receiving services according to Z-CAN program strategies were more likely than those who did not to be very satisfied with services. Women who received high-quality client-centered contraceptive counseling and same-day access to the method they were most interested in after counseling were also more likely to be very satisfied with the contraceptive method received. CONCLUSIONS: A contraception access program can be rapidly implemented with high fidelity to program strategies in a fast-moving and complex public health emergency setting.

Brief Report: HIV Shedding in the Female Genital Tract of Women on ART and Progestin Contraception: Extended Follow-up Results of a Randomized Clinical Trial.

BACKGROUND: Progestin contraception has been linked to higher risk of female to male sexual HIV transmission. SETTING: A clinical trial among HIV-infected women in Lilongwe, Malawi, randomized to initiation of depomedroxyprogesterone acetate injectable or levonorgestrel implant, and followed for up to 33 months, with the outcome of HIV shedding in the genital tract. METHODS: We compared the frequency and magnitude of HIV genital shedding before and after initiation of contraception and between study arms among women receiving antiretroviral therapy (ART). Genital HIV RNA was measured in TearFlo Strips using the Abbott RealTime HIV-1 assay. RESULTS: Among 68 HIV-infected Malawian women on ART, randomization to depot medroxyprogesterone acetate compared with the levonorgestrel implant was not associated with genital shedding and neither progestin contraceptive was associated with increased HIV genital shedding, for up to 33 months after contraceptive initiation. Having detectable plasma HIV [adjusted risk ratio (RR) 10.5; 95% confidence interval (CI): 3.18 to 34.7] and detectable genital shedding before contraceptive initiation (adjusted RR 3.53; 95% CI: 1.31 to 9.47) were associated with a higher risk of detectable genital shedding after contraceptive initiation. Higher plasma efavirenz concentrations were associated with a lower risk of detectable genital shedding (adjusted RR 0.85; 95% CI: 0.73 to 0.99, per increase of 1000 ng/mL). CONCLUSION: Among HIV-infected women receiving ART, our results provide evidence that progestin contraception does not impact women's risk of transmission of HIV to partners. Our finding that detectable genital shedding before contraceptive initiation independently predicts shedding suggests that there may be other individual-level biological or behavioral factors that increase the risk for shedding.

Effect of the depot medroxyprogesterone acetate injectable and levonorgestrel implant on HIV genital shedding: a randomized trial.

OBJECTIVES: To assess the effect of the depot medroxyprogesterone acetate injectable (DMPA) and of the levonorgestrel (LNG) implant on genital HIV shedding among women receiving antiretroviral therapy (ART). METHODS: We randomized HIV-infected Malawian women to either DMPA or LNG implant from May 2014 to April 2015. HIV RNA was measured in cervicovaginal lavage (CVL) fluid and TearFlo Strips (TFS), and HIV DNA was measured in cells collected by CVL. We compared the frequency and magnitude of HIV genital shedding before and for 6 months after initiation of contraception and between arms among women receiving ART. We also compared genital HIV RNA levels obtained by sample type (TFS versus CVL). RESULTS: We analyzed data for 68 HIV-infected women receiving ART: 33 randomized to DMPA and 35 randomized to the LNG implant. Overall, HIV RNA was more often detectable and the quantity was higher on TFS compared with CVL. HIV DNA was detected very rarely in CVL cell samples (4 of 360 samples). The frequency of genital shedding and the genital HIV quantity did not increase after contraceptive initiation with either DMPA or LNG implant among women receiving ART. CONCLUSIONS: HIV-infected women receiving ART initiating contraception with either DMPA or LNG implant did not have any increase in genital HIV shedding during the first 6 months of contraceptive use. These findings are consistent with growing evidence that progestin contraception is not associated with increased HIV transmission risk from such women to their male partners. Consistent with other studies, genital HIV RNA detection was higher in TFS than in CVL fluid. IMPLICATIONS: In this randomized trial, neither DMPA nor the LNG implant, two of the most commonly used hormonal contraceptives among African women with HIV, was associated with increased genital HIV shedding in HIV-infected women receiving ART. These findings are reassuring and add to the currently limited information available for the highly effective contraceptive, LNG implant.

The Zika Contraception Access Network: a feasibility programme to increase access to contraception in Puerto Rico during the 2016-17 Zika virus outbreak.

BACKGROUND: Prevention of unintended pregnancy is a primary strategy to reduce adverse pregnancy and birth outcomes related to Zika virus infection. The Zika Contraception Access Network (Z-CAN) aimed to build a network of health-care providers offering client-centred contraceptive counselling and the full range of reversible contraception at no cost to women in Puerto Rico who chose to prevent pregnancy during the 2016-17 Zika virus outbreak. Here, we describe the Z-CAN programme design, implementation activities, and baseline characteristics of the first 21 124 participants. METHODS: Z-CAN was developed by establishing partnerships between federal agencies, territorial health agencies, private corporations, and domestic philanthropic and non-profit organisations in the continental USA and Puerto Rico. Private donations to the National Foundation for the Centers for Disease Control and Prevention (CDCF) secured a supply of reversible contraceptive methods (including long-acting reversible contraception), made available to non-sterilised women of reproductive age at no cost through provider reimbursements and infrastructure supported by the CDCF. To build capacity in contraception service provision, doctors and clinic staff from all public health regions and nearly all municipalities in Puerto Rico were recruited into the programme. All providers completed 1 day of comprehensive training in contraception knowledge, counselling, and initiation and management, including the insertion and removal of long-acting reversible contraceptives (LARCs). Z-CAN was announced through health-care providers, word of mouth, and a health education campaign. Descriptive characteristics of programme providers and participants were recorded, and we estimated the factors associated with choosing and receiving a LARC method. As part of a Z-CAN programme monitoring plan, participants were invited to complete a patient satisfaction survey about whether they had obtained free, same-day access to their chosen contraceptive method after receiving comprehensive counselling, their perception of the quality of care they had received, and their satisfaction with their chosen method and services. FINDINGS: Between May 4, 2016, and Aug 15, 2017, 153 providers in the Z-CAN programme provided services to 21 124 women. 20 110 (95%) women received same-day provision of a reversible contraceptive method. Whereas only 767 (4%) women had used a LARC method before Z-CAN, 14 259 (68%) chose and received a LARC method at their initial visit. Of the women who received a LARC method, 10 808 (76%) women had used no method or a least effective method of contraception (ie, condoms or withdrawal) before their Z-CAN visit. Of the 3489 women who participated in a patient satisfaction survey, 3068 (93%) of 3294 women were very satisfied with the services received, and 3216 (93%) of 3478 women reported receiving the method that they were most interested in after receiving counselling. 2382 (78%) of 3040 women rated their care as excellent or very good. INTERPRETATION: Z-CAN was designed as a short-term response for rapid implementation of reversible contraceptive services in a complex emergency setting in Puerto Rico and has served more than 21 000 women. This model could be replicated or adapted as part of future emergency preparedness and response efforts. FUNDING: National Foundation for the Centers for Disease Control and Prevention.