Dataset Information

Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.

ABSTRACT: OBJECTIVE:To assess the supply- and demand-side factors influencing continued use of the injectable contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC). METHODS:We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting to clinic-based providers (CBPs) at 6 Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered by a provider or be trained to self-inject DMPA-SC. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, and safety by whether DMPA-SC or self-injection training was provided by CHWs versus CBPs. We also conducted an exploratory analysis assessing the association between women's sociodemographic factors and the risk for discontinuation using stratified Cox proportional hazards models. FINDINGS:The type of provider did not seem to influence continuation, pregnancy, or safety. As reported previously, women in the self-injection group were significantly less likely to discontinue the method compared with women in the provider-administered group (hazard ratio, 0.43; P<.001). The risk for discontinuation was also different among health facility catchment sites (P<.001). No other assessed sociodemographic factors were found to significantly influence the risk for discontinuation. CONCLUSIONS:Public-sector CHWs can safely and effectively provide DMPA-SC and train women to self-inject DMPA-SC in low-resource settings. DMPA-SC continuation did not seem to be influenced by the type of provider, whether CBP or CHW, or women's sociodemographic characteristics.

SUBMITTER: Burke HM

PROVIDER: S-EPMC6538126 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.

Burke Holly M HM Chen Mario M Buluzi Mercy M Fuchs Rachael R Wevill Silver S Venkatasubramanian Lalitha L Santo Leila Dal LD Ngwira Bagrey B

Global health, science and practice 20190329 1

<h4>Objective</h4>To assess the supply- and demand-side factors influencing continued use of the injectable contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC).<h4>Methods</h4>We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting to clinic-based providers (CBPs) at 6 Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered ...[more]

PMID: 30894394

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Project description:Since the introduction of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in 2018, Malawi has achieved national coverage of trained providers in the public sector and steady increases in uptake of DMPA-SC. However, the rate of clients opting to self-inject DMPA-SC has remained lower than early acceptability studies suggested. Providers play an instrumental role in building client confidence to self-inject through counselling/training. This cross-sectional qualitative study explored the perspectives of providers and injectable clients on the integration of self-injection into contraceptive counselling, to identify best practices and potential gaps. The study was conducted at public sector sites in three districts (Nkhotakota, Mzimba South, Zomba) in Malawi. In-depth interviews were conducted with provider-administered injectable clients, self-injecting clients, and DMPA-SC trained providers. All providers interviewed reported successfully integrating self-injection into their approach. During group health education sessions, some providers reported focusing on benefits of self-injection to spark interest in the method, and then follow that up with more in-depth information during individual counselling. Due to time pressures, a minority of providers reported replacing individual counselling with small-group counselling and limited use of elements such as visualizations and demonstrations. Most providers skipped client practice on inanimate objects, feeling this was either not necessary or inappropriate given stock constraints. Self-injection clients tended to credit their decision to take up SI to receiving lengthy, comprehensive counselling/training, often inclusive of reassuring messages, visualizations, demonstrations and sometimes repeated trainings over time. Provider-administered clients tended to credit their lack of uptake of self-injection to fear and lack of confidence, often blaming themselves instead of the quality of their counselling/training-even while many felt their counselling/training had been rushed or incomplete. Providers should be supported to overcome time- and resource-pressures to invest in counselling/training best practices, to ensure sufficient support is provided to clients interested in self-injection.

Project description:ObjectivesExpanding contraceptive options through self-injection may improve access and confidentiality. There are few published studies on contraceptive self-injection in sub-Saharan Africa and none in West Africa, a region with high unmet need. This study was performed to assess feasibility of subcutaneous DMPA self-injection in Senegal; objectives were to (1) measure the proportion of participants who self-injected competently 3 months after training, (2) measure the proportion who self-injected on time (defined conservatively as within 7 days of reinjection date), and (3) assess acceptability of self-injection.Study designIn this prospective cohort study, 378 women aged 18-49 years were trained to self-inject by study nurses. Three months later, women returned unprompted to the clinic to self-inject, and technique and visit timing were evaluated. Women continuing with a third self-injection were followed up at home after their next scheduled injection date. At each interaction, participants were interviewed to learn about their experience; additional questions during the final home visit focused on storage and disposal practices, and acceptability.ResultsAmong the 337 participants followed up 3 months post-training, 310 self-injected, and 87% did so competently. Factoring in women who declined to self-inject, electing to have the provider administer the injection instead, a total of 80% [95% confidence interval (CI)=75-84%] self-injected competently 3 months post-training, and 84% [95% CI=80-88%] reinjected on time, while 72% [95% CI=67-77%] were both on time and competent. The vast majority (93%) expressed a desire to continue.ConclusionsSelf-injection is feasible and acceptable among most study participants in Senegal.ImplicationsThese first research results on contraceptive self-injection in West Africa indicate initial feasibility and acceptability of the practice. Results underscore the importance of designing self-injection programs that empower and support women, including those with limited education.

Project description:ObjectivesTo evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (sc) depot medroxyprogesterone acetate (DMPA).Study designWomen presenting to a family planning clinic to initiate, restart or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self- or clinician administered sc DMPA 104 mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months.ResultsTwo hundred fifty women were invited to participate, and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer sc DMPA. Eighty-seven percent completed follow-up. DMPA use at 1 year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at 1 year (p=0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants.ConclusionsSixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of sc DMPA is feasible and may be an attractive alternative for many women.ImplicationsSelf-administration of sc DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA.

Project description:OBJECTIVES:The subcutaneous depot medroxyprogesterone acetate (DMPA-SC) injectable contraceptive was introduced in South West Nigeria in 2015 through private sector channels. The introduction included community-based distribution and was supported by a social marketing approach. From program monitoring and evaluation, aimed at understanding performance, market reach and other process measures, we identify lessons learned to inform future scale-up efforts. METHODS:We synthesized the findings from a core set of key performance indicators collected through different methods: (1) implementer performance indicators, (2) phone survey of DMPA-SC users (n=541) with a follow-up after 3 months (n=342) and (3) in-depth interviews with 57 providers and 42 users of DMPA-SC. RESULTS:Distribution of DMPA-SC to private providers was concentrated in states with large urban populations. A shift toward focusing on high-volume family planning facilities coincided with a rapid increase in distribution in late 2016. Users reached in the phone survey were generally older and married with children; few were under age 25. Users and providers reported favorable opinions of DMPA-SC. Many users reported choosing DMPA-SC due to recommendations from providers and friends, and the hope of experiencing reduced side effects compared to other methods. While users reported positive experiences interacting with community-based distributors, the delivery model encountered a number of challenges - high turnover, low motivation, lack of an appropriate compensation package and logistical costs - and was ultimately disbanded. CONCLUSIONS:In the DMPA-SC introductory program in Nigeria, distribution was amplified when focused on high-volume contraceptive providers. Although community-based distribution can be one effective service delivery model for reaching underserved populations, more consideration for balancing cost recovery and public health goals through private sector approaches are needed in the context of South West Nigeria. Additional communications and outreach efforts are needed to reach younger, unmarried users with contraceptive services.

Project description:ObjectivesThis study aimed to evaluate and compare local tolerability of investigational drug TV-46046 and reference drug Depo-subQ Provera 104, both containing medroxyprogesterone acetate (MPA) as an active ingredient.Study designWe conducted a randomized, crossover, single-center study. Twenty-seven healthy women aged 25 to 47 years at low risk of pregnancy received a subcutaneous injection of each of the four study drugs (120 mg/0.3 mL of TV-46046, 60 mg/0.3 mL of diluted TV-46046, 0.3 mL of TV-46046 placebo, and 104 mg/0.65 mL of Depo-subQ 104) in different quadrants of the abdomen. We assessed local tolerability by occurrence of injection site reactions (ISRs), as well as injection site pain and overall safety for at least 9 months postinjections.ResultsOf a total of 108 study injections, three injections were partial due to needle blockage. We observed a total of 30 ISRs following 105 full-dose injections, including hypopigmentation (n = 24), bruising (n = 4), and atrophy/dimple (n = 2). Eleven cases of hypopigmentation occurred following 25 full-dose injections of undiluted TV-46046 (44.0%), six following 27 full-dose injections of diluted TV-46046 (22.2%), and seven following 26 full-dose injections of Depo-subQ 104 (26.9%). Hypopigmentations occurred on average 8 months postinjection. Injection pain was minimal and dissipated quickly after all four injections.ConclusionsSubcutaneous administration of MPA in a suspension formulation is associated with the delayed onset of hypopigmentation at the site of injection. Although not statistically significant, the rate of ISRs was over 60% higher for undiluted TV-46046 compared to Depo-subQ 104. This difference bears careful monitoring in future studies of TV-46046.ImplicationsFrom a safety standpoint, investigational drug TV-46046 is appropriate for further clinical testing as a 6-month contraceptive injectable. The previously underreported hypopigmentation associated with subcutaneous administration of MPA warrants further investigation and acceptability assessment among users of existing Depo-subQ 104 as well as careful monitoring of local tolerability of TV-46046 in future clinical trials.Trial registrationRegistered at clinicaltrials.gov no: NCT02817464.

Dataset Information

Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.

Publications

Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.

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