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. Author manuscript; available in PMC: 2023 May 15.
Published in final edited form as: Ann Intern Med. 2022 May 24;175(7):980–993. doi: 10.7326/M21-4380

Effectiveness and Harms of Contraceptive Counseling and Provision Interventions for Women: A Systematic Review and Meta-analysis

Heidi D Nelson (1), Amy Cantor (2), Rebecca M Jungbauer (2), Karen B Eden (2), Blair Darney (2),(3),(4), Katherine Ahrens (5), Amanda Burgess (5), Chandler Atchison (2), Rose Goueth (2), Rongwei Fu (2)
PMCID: PMC10185303  NIHMSID: NIHMS1893999  PMID: 35605239

Abstract

Background:

The effectiveness and harms of contraceptive counseling and provision interventions are unclear.

Purpose:

To evaluate evidence of the effectiveness of contraceptive counseling and provision interventions for women to increase use of contraceptives, reduce unintended pregnancy, or cause harms.

Data Sources:

English-language searches of Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, PsycINFO, SocINDEX, and MEDLINE (1/1/2000-2/3/2022); reference lists.

Study Selection:

Randomized controlled trials of interventions providing enhanced contraceptive counseling, provision of contraceptives, or both versus usual care or active control.

Data Extraction:

Dual extraction and quality assessment of studies; results combined by profile likelihood random-effects model.

Data Synthesis:

38 trials (43 articles [25,472 participants]) met inclusion criteria. Contraceptive use was higher with various counseling interventions versus usual care or active control in different clinical settings (risk ratio [RR], 1.39 [95% CI, 1.16-1.72]; I2=85.3%; 10 trials); provision of emergency contraception in advance of use (RR, 2.12 [95% CI, 1.79-2.36]; I2=0.0%; 8 trials); and counseling or provision postpartum (RR, 1.15 [95% CI, 1.01-1.52]; I2=6.6%; 5 trials) or at the time of abortion (RR, 1.19 [95% CI, 1.09-1.32]; I2=0.0%; 5 trials). Pregnancy rates were generally lower with interventions, although most trials were underpowered and did not distinguish pregnancy intention. Risks were similar for STIs (RR, 1.05 [95% CI, 0.87-1.25]; I2=0.0%; 5 trials) and condom use (RR, 1.03 [95% CI, 0.94-1.13]; I2=0.0%; 6 trials).

Limitations:

Interventions varied; few trials were adequately designed to determine unintended pregnancy outcomes.

Conclusions:

Contraceptive counseling and provision interventions that provide services beyond usual care increase contraceptive use without increasing STIs or reducing condom use. Contraceptive care in clinical practice could be improved by implementing enhanced contraceptive counseling, provision, and follow-up; providing emergency contraception in advance; and delivering contraceptive services immediately postpartum or at the time of abortion.

INTRODUCTION

Despite the availability of effective contraception (1, 2), nearly half of pregnancies in the United States are unintended (3). Assuring delivery of comprehensive contraceptive care, particularly for those facing barriers to access, is a responsibility of clinicians providing health care to women.

Contraceptive care supports women in achieving their reproductive goals by providing counseling, provision, and follow-up services as needed. Delivering contraceptive care as a preventive health service is a standard of care in the United States and covered for most women under the provisions of the Patient Protection and Affordable Health Care Act of 2010 (4). Several national and professional organizations have issued recommendations for contraceptive use (5-13), and the safety and effectiveness of U.S. Food and Drug Administration approved and cleared contraceptives are well established (1, 2).

In contrast to these standards, contraceptive care remains a preventive services gap. Access and coverage are frequently challenged (14-18), and influential guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care. The evidence to determine benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to other preventive services, and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices. This systematic review and meta-analysis addresses this need by determining the effectiveness of contraceptive counseling and provision interventions for women and adolescents in various clinical settings that extend beyond routine care to increase use of contraceptives, reduce unintended pregnancy, or cause harms.

METHODS

This systematic review includes randomized controlled trials (RCTs) of interventions providing contraceptive counseling, provision of contraceptives, or both for women compared with usual care or active control delivered in settings relevant to clinical practice in the United States.

This analysis is part of a larger systematic review that was used to update national clinical practice recommendations (13). A research protocol (PROSPERO CRD42020192981 (19)) was developed in collaboration with methodological and content experts convened for this review and incorporates standard methods (20). An analytic framework and key questions guided the review (Appendix Figure 1). This analysis summarizes evidence most applicable to clinical practice and includes RCTs of the effectiveness of contraceptive counseling and provision interventions to increase use of contraceptives, reduce unintended pregnancy, or cause harms. The efficacy of specific contraceptive methods to prevent pregnancy and their adverse effects are well-established (21, 22) and outside the scope of this review.

Data Sources and Searches

Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, PsycINFO, SocINDEX, and Ovid MEDLINE (January 1, 2000, to February 3, 2022) databases were searched for relevant English-language articles published since 2000 (see Supplement). Reference lists of key studies and systematic reviews were manually reviewed.

Study Selection

Two investigators independently reviewed abstracts and full-text articles to identify studies meeting prespecified eligibility criteria (see Supplement); discrepancies were resolved by discussion and consensus. Investigators tracked results in an EndNote database (Thomson Reuters).

The target population includes individuals with potential for becoming pregnant without the use of contraception and uses an inclusive definition of women (i.e., biological females of all gender identities). Trials were included that evaluated the effectiveness of contraceptive counseling, provision of contraceptives, or both that extended beyond routine care compared with patients receiving usual care or active controls. Contraceptive counseling includes education and consideration of a patient’s benefits, harms, and preferences, among other components, often involving an explicit shared decision-making process. Education alone is less comprehensive than counseling and generally involves relaying information to patients rather than interactive engagement. Trials of interventions that included only an education component were not included. Provision of contraceptives includes instructing, prescribing, delivering (e.g., placement of IUD and implants), and dispensing (e.g., pill packs) contraceptives as well as providing follow-up care. Contraceptives included U.S. Food and Drug Administration approved or cleared devices, medications, and other methods that were in clinical use in the United States as of 2020 (23).

Outcomes included contraceptive use and unintended pregnancy within 12 months of the intervention. Potential harms included any adverse outcome related to the intervention, such as anxiety, stigma, reproductive coercion, sexually transmitted infections (STIs), and lack of condom use. Contraceptive care can be delivered in a variety of settings (e.g., health care clinics, health care systems, affiliated sites, educational facility, pharmacy) by a broad range of health care workers (e.g., physicians, nurses, pharmacists, counselors).

Data Extraction and Assessment of Quality and Applicability

A single investigator abstracted data into tables including methods, participant characteristics, settings, interventions, comparators, and outcomes. A second investigator reviewed data for accuracy.

Two investigators independently applied criteria developed by the U.S. Preventive Services Task Force to assess the quality and applicability of each study as good, fair, or poor (24) (see Supplement). Applicability considers the extent to which factors related to the study population, setting, and providers in trials are likely to reflect the expected results when an intervention is applied under real-world conditions. Discrepancies were resolved through consensus with a third reviewer.

Data Synthesis and Analysis

Strength of evidence and applicability for each key question and outcome were based on the number, quality, and size of studies; the consistency of results between studies; and directness of evidence (20) (see Supplement). Strength of evidence was assessed by one investigator and then reviewed by all investigators for consensus and graded high, moderate, low, or insufficient.

Statistical Meta-analysis

Results were combined using meta-analysis for trials providing sufficient data. Outcomes from the most common follow-up times were used and generally ranged from 3 to 12 months after the intervention. Estimates of risk ratios (RRs [rate ratio, hazard ratio, or relative risk]) and their standard errors were abstracted (for cluster-randomized trials where intra-cluster correlation was adjusted) or calculated from each study and used as effect measures.

The presence of statistical heterogeneity among studies was assessed using Cochran’s χ2 tests, and the magnitude of heterogeneity using the I2 statistic (25). The RRs were combined by using a profile likelihood random-effects model to account for variation among studies (26). Analyses were performed by using Stata/SE 16.1 (StataCorp, College Station, TX), and results were provided with 95 percent confidence intervals. To minimize clinical heterogeneity across trials of interventions, meta-analysis and sub-group analysis were based on interventions and settings when sufficient trials were available to combine results.

Potential for publication bias was evaluated using Egger's test (27) for small-study effects for meta- analyses that included eight or more studies.

Role of the Funding Source

Investigators worked with a stakeholder panel that included the funder to develop the scope, analytic framework, and key questions for this review. The funder had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings. The opinions expressed in this document are those of the authors and do not reflect the official position of the funder.

RESULTS

A total of 38 RCTs (43 articles [25,472 participants]) met inclusion criteria for this analysis, representing a sub-set of the complete search of 17,454 citations (Appendix Figure 2). These include 36 trials reporting contraceptive use (28-65) and 11 reporting pregnancy as a primary or secondary outcome (29, 31, 35, 36, 43, 47, 50, 52, 66-68). Seven trials evaluated STIs and lack of condom use as potential harms of interventions (35, 36, 39, 42-45, 67, 69, 70). No trials reported other harms, such as anxiety, stigma, and reproductive coercion, among others. Several trials reported multiple outcomes. Included trials and their quality and applicability ratings are further described in the Supplement.

Most trials met criteria for good or fair quality; 11 trials were rated poor quality. The most common methodologic limitations included lack or inadequate reporting of randomization, allocation concealment, and masking of patients and outcome assessors. While blinding and masking are essential in effectiveness trials of medications, these measures are often not feasible in trials of contraceptive care interventions. Consequently, all trials meeting eligibility criteria were included regardless of quality rating. All but three trials met criteria for good or fair applicability. For most trials, the study population, setting, and providers were similar to clinical practice in the United States suggesting that the clinical experience with the intervention observed in the trials will likely be attained in practice.

Interventions included one or more components of contraceptive care that extended beyond the usual care or active control provided to the comparison group. These included structured or enhanced counseling; specialized educational materials; individualized information; decision support tools and computer modules; enhanced care after contraception training of clinicians; additional onsite or support services, such as social workers; provision of contraceptives at times or settings outside routine practice; referrals; and follow-up. Individual components of interventions varied across trials (Table 1). Comparison groups included patients receiving usual care or an active control that differed from the intervention, such as receiving generic educational materials versus individualized information.

Table 1.

Contraceptive Counseling and Provision Interventions in Trials

Study, Year
(Reference)		 Population (N) Setting (number of sites);
location		 Comparison Intervention
Trials in clinical populations
Stevens, 2017 (36) Adolescent mothers (598) OB-GYN clinics (7), hospital postpartum units (5); US Usual clinical care; educational handouts on contraceptives Monthly home visits and telephone calls; transportation; social worker; contraceptive clinic visits
Tebb, 2021 (37) Adolescents (1,360) School based health centers (18); US Baseline survey Computer app with tailored recommendations; printout to review with clinician
Dehlendorf, 2019 (28) Adolescents and women (758) Family planning, public health, student, and outpatient clinics (4); US Routine contraceptive counseling Educational materials and personalized recommendations; interactive computer decision support tool
Shlay, 2003 (35) Adolescents and women (877) Urban STD clinic (1); US Condoms with spermicide and a referral list of primary care clinics Enhanced counseling; provision of contraceptives and condoms with spermicide; referral to primary care
Harper, 2015; El Ayadi, 2017; 2021 (66, 69, 70) Adolescents and women (1,356) Abortion care (17) and family planning clinics (23); US Usual clinical care without specialized clinician training Clinician training on LARC knowledge, counseling, and insertion
Reyes-Lacalle, 2020 (33) Pregnant and postpartum women (1,004) National reproductive health clinics (20); Spain Routine contraceptive counseling Enhanced prenatal and postpartum counseling; educational materials
Emtell, 2021 (29) Women (1,364) Abortion, youth, maternal health clinics (33); Sweden Routine contraceptive counseling Structured contraceptive counseling; standardized materials
Mazza, 2020 (32) Women (740); family physicians (57) Family medicine clinics; Australia Usual clinical care without specialized clinician training Clinician training on LARC knowledge, counseling, and insertion
Garbers, 2012 (30) Women (269) Public family planning clinics (2); US Brief version of computer module with generic contraception information Educational materials; individualized contraception information; contraception computer module
Schwarz, 2013 (34) Women (814) Emergency departments (3), urgent care clinic (1); US Computer module on chlamydia screening Educational materials; computer module on OC; offer of prescription for OC, ring, or patch
Heil, 2021 (31) Women (138) Opioid treatment program (1); US Usual clinical care Onsite contraceptive services, financial incentives; follow-up visits
Trials of advance provision of emergency contraception
Gold, 2004 (39) Adolescents (301) Hospital-based adolescent clinic (1); US Information about EC use, risks, and access; EC access when needed Usual care information; one course advance EC; access to 2 additional courses
Belzer, 2005 (38) Adolescent mothers (160) Case management program (1); US Information about contraception and EC Instructions for EC refills; contraception information; one course advance EC
Lo, 2004 (40) Women (1,030) Family planning clinics (2); Hong Kong Information on EC and instructions on access when needed Information on EC; three courses advance EC
Ekstrand, 2008; Ekstrand, 2013 (44, 45) Adolescents seeking EC (420) Youth clinic (1); Sweden Single course EC for immediate use; follow up for contraceptive counseling and pregnancy test Leaflet about EC and condom use; two courses EC for immediate and future use; 10 condoms; follow up for contraceptive counseling and pregnancy test
Harper, 2005; Raine, 2005; Rocca, 2007 (41, 42, 67) Adolescents and women (2,117) Family planning clinics (4); US Instruction card to return to the clinic for EC if needed Three courses advance EC
Schwarz, 2008 (47) Women (446) Urgent care clinics (2); US Counseling on preconception folate; sample of folate Contraceptive counseling; two courses advance EC
Jackson, 2003 (46) Postpartum women (371) Public hospital (1); US Routine contraceptive counseling 5-minute education session; brochure; one course advance EC with instructions
Raymond, 2006 (43) Adolescents and women (1,490) NR Advice on obtaining EC if needed Two courses advance EC with replacements as needed
Trials of counseling and provision immediately postpartum
Chen, 2010 (49) Postpartum women (163) Women's hospital (1); US IUD insertion 8 weeks post delivery Immediate IUD insertion post delivery
Bryant, 2017 (48) Postpartum adolescents and women (96) Academic hospital (1); US Implant at postpartum visit 6 weeks post delivery Contraceptive implant placed before hospital discharge
Torres, 2018 (51) Postpartum women with preterm births (134) Academic Hospital (1); US Routine postpartum care Counseling script of contraceptive methods, risks, benefits, and side effects
Frarey, 2019 (50) Postpartum adolescents (100) University hospital (1); US Routine contraceptive counseling Counseling with emphasis on LARC safety and efficacy; empowerment messaging; shared decision making
Trials of counseling and provision at time of abortion
Bednarek, 2011 (52) Adolescents and women post surgical abortion (575) Family planning clinics and university clinic (4); US IUD insertion 2-6 weeks post abortion IUD insertion within 15 minutes post abortion
Shimoni, 2011 (55) Women post medication abortion (156) University medical center (1); US IUD insertion 4-6 weeks post abortion IUD insertion 1-week post abortion
Whitaker, 2016 (56) Adolescents and women post medication abortion (60) Academic medical center (1); US Non-standardized contraception counseling and provision of contraceptive 7-step motivational counseling session with USAID/WHO guide + usual care
Schunmann, 2006 (54) Women post-surgical or medication abortion (613) Abortion clinic (1); Scotland Contraceptive discussion before abortion; contraceptives after procedure or at clinic or 1-month supply of OC; condoms; educational materials Usual care + 15–20-minute consultation with physician contraception specialist; immediate IUD, implant, Depo Provera, or 3-month supply of OC as chosen
Langston, 2010 (53) Women post-surgical abortion (222) Family planning referral clinic (1); US Usual care with provision of contraceptive Counseling with 2005 WHO decision aid; samples of each type; provision of contraceptive of choice
Pohjoranta, 2015 (68) Women (748) Hospital clinic; Finland 1-year supply of OC Immediate IUD
Trials of pharmacist provided contraceptives
Michie, 2014 (58) Adolescents and women receiving EC from pharmacies (168) Pharmacies (11); Scotland Standard dispensing procedures Pharmacist provision of one packet of 35 progestogen-only pills; instructions to take empty packet of EC to local specialist to discuss contraception
Cameron, 2020 (57) Adolescents and women receiving EC from pharmacies (406) Pharmacies (29); UK Standard advice to see usual clinician for contraception Pharmacist provision of three packets of progestogen-only pill; rapid access card to local clinic
Trials to increase contraceptive continuation
Kohn, 2018 (62) Adolescents and women (401) Family Planning Clinics (3); US DMPA administered by clinic personnel Taught to self-inject DPMA with printed instructions
Kirby, 2010 (65) Adolescents (805) Urban reproductive health clinic (1); US Usual clinic services Nine follow-up phone calls to take OC
Berenson, 2012 (59) Adolescents and women (1,155) Publicly funded reproductive health clinics (5); US Oral and written instructions, 4-month supply of OCs and 24 free condoms; additional 9-month supply at 3-month follow up Standard care and individual session with contraceptive counselor; weekly phone calls until OC initiation, then monthly calls for 6 months; post-clinic visit
Castano, 2012 (64) Adolescents and women (962) Planned Parenthood clinic (1); US Routine contraceptive counseling, educational materials Daily text reminders to take OC; education messages
Hou, 2010 (61) Women (82) Planned Parenthood Clinic (1); US Standard care Daily text reminders to take OC
Edwards, 2008 (60) Adolescents (539) Urban clinics (2); US Standardized instructions, 3-month supply of OC pills Directly observed ingestion in clinic after negative pregnancy test, 3-month supply
Westhoff, 2007 (63) Adolescents and women (1,716) University-based family planning clinics; US Standard instructions, package of OC pills Directly observed ingestion in clinic, package of OC pills
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DMPA, depot medroxyprogesterone acetate; EC, emergency contraception; IUD, intrauterine device; LARC, long-acting reversible contraception; NR, not reported; OB-GYN, obstetrics and gynecology; OC, oral contraceptive; STD, sexually transmitted disease; WHO, World Health Organization.

Meta-analysis included estimates of contraceptive use for trials of counseling and provision in clinical settings; advance provision of emergency contraception; and delivery immediately postpartum or at the time of abortion. Sub-group analysis evaluated counseling and provision interventions separately within these groups when feasible. Risks of STIs and lack of condom use were evaluated separately as potential adverse effects.

Too few trials of additional interventions or outcomes were available or appropriate for meta-analysis. Unintended pregnancy outcomes were not combined in meta-analysis because trials used different assumptions or definitions of pregnancy intention or did not differentiate unintended pregnancy from pregnancy in general. Also, trials were frequently underpowered to measure differences in pregnancy rates between intervention and comparison groups and had high or unclear attrition and loss to follow-up. These limitations restricted interpretation of results.

Effectiveness of Counseling and Provision Interventions for Adolescents and Adult Women in Clinical Settings

Ten trials evaluated contraceptive use after counseling and provision interventions compared with usual care or active controls in populations of adolescents and adult women in various clinical settings (28-37). Trials compared enhanced versus routine contraceptive counseling (29, 33, 36); contraceptive electronic support tools versus alternative tools or usual care (28, 30, 34, 37); onsite contraceptive services that included follow-up and payment incentives versus usual care (31); care provided after family physician training on long-acting, reversible contraception (LARC) including intrauterine devices (IUDs) and implants versus care provided after no training (32); and monthly home visits and follow-up calls versus usual care (36).

Adolescents (28, 35-37) and adult (29-35) women were enrolled from multiple clinical settings including family planning clinics, family medicine and obstetrics and gynecology clinics, STI clinics, school-based health clinics, emergency departments and urgent care clinics, an opioid treatment center, public and national health clinics, and hospital postpartum units. Contraceptives included LARC specifically (29, 32, 36) or categories described as ‘effective types’ including IUDs, implants, injectable contraceptives, combined oral contraceptives, progestin-only pills, contraceptive ring, and contraceptive patch with the addition of male and female sterilization for some studies (13, 30, 31).

A meta-analysis of trials indicated 39% higher contraceptive use 3 to 6 months after interventions compared with usual care or active control (RR, 1.39 [95% CI, 1.16-1.72]; I2=85.3%; 10 trials [n=5,239]) (Figure 1). The included studies demonstrated no evidence of small study effects (Egger test, P=0.063; see Supplement).

graphic file with name nihms-1893999-f0001.jpg

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Five RCTs reported pregnancy as a primary or secondary outcome including four trials with contraceptive use outcomes included in the meta-analysis (29, 31, 35, 36) and an additional trial that reported pregnancy but not contraceptive use (66). Of these, three trials used self-reported measures to indicate whether a pregnancy was unintended (31, 35, 36) and two reported general pregnancy outcomes (29, 66). Unintended pregnancy rates were lower after interventions compared with usual care in a trial of adolescent mothers receiving contraception supportive services (17.2% vs 34.7%, n=598) (36); a trial of enhanced contraception counseling in an urban STI clinic (21.9% vs 26.5%, n=877) (35); and a trial of onsite services and incentives in an opioid treatment program (services and incentives 4.9% vs services alone 16.7% vs usual care 22.2%; n=138) (31). Pregnancy rates did not differ in a trial comparing structured with routine counseling in Sweden (29). In a cluster randomized trial comparing clinician training on LARC procedures and patient education videos with usual care, pregnancy rates at 12 months were lower for women attending family planning clinics (hazard ratio [HR], 0.54 [95% CI 0.34-0.85]), but not for women attending abortion clinics (HR, 1.35 [95% CI 0.91-2.02]) (66).

Effectiveness of Advance Provision of Emergency Contraception

Providing emergency contraception in advance for women not using contraception or at risk of contraceptive failure assures its availability when needed. Eight trials (in 10 publications) compared use of emergency contraception among women receiving advance provision with those receiving information without provision (38-43), routine contraceptive counseling (44-46), or counseling on a nonrelated topic (47). In a meta-analysis, emergency contraception use at 6 months was over twice as high among women receiving advance provision compared with controls (RR, 2.12 [95% CI, 1.79-2.36]; I2=0.0%; 8 trials [n=4,796]) (Figure 2). Results were consistent across trials regardless of patient population, setting, or comparison group. The included studies demonstrated no evidence of small study effects (Egger test, P=0.86) (see Supplement).

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Pregnancy rates were lower at 6 months follow-up in a trial of counseling and advance provision of emergency contraception compared with counseling and provision of preconception folate (0.5% vs 4.0%, n=265) (47). Pregnancy rates did not differ at 6 or 12 months in two additional trials comparing advance provision of emergency contraception with information about how to obtain it (43, 67).

Effectiveness of Counseling and Provision Interventions Immediately Postpartum

Five trials compared contraceptive use among postpartum women receiving contraceptive counseling and provision prior to hospital discharge with those receiving usual care (46, 48-51). Two trials of women wanting LARC compared implant placement before hospital discharge versus at the 6-week postpartum visit (48); or immediate IUD insertion post-delivery versus IUD insertion at the 8-week postpartum visit (49). The other three studies compared enhanced postpartum contraceptive counseling versus routine counseling (50, 51); and advance provision of emergency contraception versus routine counseling (46).

In a meta-analysis, postpartum women receiving contraceptive care prior to discharge had 15% higher rates of contraceptive use at 3 to 6 months compared with usual care (RR, 1.15 [95% CI, 1.01-1.52]; I2=6.6%; 5 trials [n=644]) (Figure 2). Results were generally consistent across trials even though the populations, types of interventions, and contraceptives varied; trials were small; and follow-up was incomplete. Subgroup analysis of the two trials of immediate versus delayed provision of IUDs (49) or implants (48); and the two trials of counseling versus usual care (50, 51) indicated increased point estimates with confidence intervals that crossed 1.0 for both types of interventions.

The only trial with pregnancy outcomes indicated no differences among 100 postpartum women receiving enhanced versus routine contraceptive counseling before hospital discharge (5 vs 4 pregnancies by 12 months) (50).

Effectiveness of Contraceptive Counseling and Provision Interventions at Time of Abortion

Five trials compared contraceptive use after interventions at the time of spontaneous or induced abortion with usual care (52-56). Two trials of women wanting LARC compared immediate IUD insertion within 15 minutes after uterine aspiration versus 2 to 4 weeks post abortion (52); and IUD insertion at 1-week post-medication abortion versus 4 to 6 weeks post abortion (55). The other three trials compared enhanced counseling and provision of chosen methods versus usual care and provision (53, 54, 56). In a meta-analysis, contraceptive use at 3 to 6 months was 19% higher for women receiving interventions compared with usual care (RR, 1.19 [95% CI, 1.09-1.32]; I2=0.0%; 5 trials [n=1,117]) (Figure 2). Results were consistent across trials regardless of population and type of intervention. Subgroup analysis of the two trials of immediate versus delayed provision of IUDs (52, 55), and the three trials of counseling versus usual care (53, 54, 56) indicated increased point estimates for both types of interventions with confidence intervals that crossed 1.0 for the counseling trials.

The only trial in the meta-analysis with pregnancy outcomes reported no unintended pregnancies at 6 months with immediate IUD insertion versus 5 unintended pregnancies with delayed insertion (52). All pregnancies occurred in women who never received an IUD in the delayed insertion group. An additional trial that did not report contraceptive use outcomes indicated fewer unintended pregnancies among women receiving immediate IUD placement at the time of surgical abortion compared with 1-year supply of oral contraceptives (2.4% vs 5.4%; n=748) (68).

Additional Trials of Effectiveness of Contraceptive Counseling and Provision Interventions

Two trials evaluated the effectiveness of pharmacist provision of oral contraceptives and contraceptive information to adolescents and women receiving emergency contraception from pharmacies in the United Kingdom (57, 58). Both trials indicated higher use with pharmacist interventions; the expanded trial reported higher use of IUDs or hormonal methods than women receiving standard care at 4-months follow-up (58.4% vs 40.5%; n=406) (57).

Seven trials evaluated the effectiveness of interventions to increase contraceptive continuation (59-65). In these trials, all participants received contraceptives and the intervention was designed to maintain use over time. Rates of injectable depot medroxyprogesterone acetate use were higher with self-injection compared with clinic administered injection in one trial (6-months, 87% vs 69%; 12-months, 69% vs 54%; n=401) (62). Methods to improve continuation of oral contraceptives were effective in one trial of daily text reminders and educational messages over 6 months but not after discontinuing reminders (rates at <6 months, 75% vs 54%; >6 months: 60% vs 54%) (64). Continuation rates of oral contraceptives did not differ between intervention and control groups in additional trials of weekly phone calls (59, 65), daily text reminders (61), and quick start approaches to initiating oral contraception (i.e., observed ingestion of the first dose of oral contraceptives in clinic) (60, 63).

Harms of Contraceptive Counseling and Provision Interventions

Seven trials of contraceptive care interventions also evaluated STIs and lack of condom use as potential adverse effects (35, 36, 39, 42-45, 67, 69, 70). Rates of STIs did not differ between intervention and comparison groups at 6 to 12-months follow-up in five trials comparing advance provision of emergency contraception with usual care (39, 42, 43, 67); individualized contraception counseling and enhanced services with usual care (35); and clinician training to improve LARC knowledge, counseling, and insertion skills with no training (69, 70) (RR, 1.05 [95% CI, 0.87-1.25]; I2=0.0%; 5 trials [n=5,051]) (Figure 3).

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Condom use or dual-use (condom with an additional method) did not differ between intervention and comparison groups at 6 or 12-months follow-up in four of the same trials (35, 39, 42, 67, 69), and in two additional trials of advance provision of emergency contraception (44, 45) and contraception support services (36) (RR, 1.03 [95% CI, 0.94-1.13]; I2=0.0%; 6 trials [n=3,898]) (Figure 3).

DISCUSSION

This systematic review and meta-analysis of 38 trials of contraceptive counseling and provision interventions for women compared with usual care or active controls demonstrates the effectiveness of multiple types of interventions to increase use of contraceptives while demonstrating no harms related to STIs or lack of condom use (Table 2). Trials enrolled adolescents and adult women from a wide range of clinical settings applicable to health care delivery in the United States.

Table 2.

Summary of Evidence

Intervention or
outcome		 Outcome
measure		 Studies; design;
participants (N)		 Summary of findings Consistency;
precision		 Limitations* Strength of
evidence;
applicability
Effectiveness of contraceptive counseling and provision interventions
General populations of adolescents and adult women Use at 3-6 months 10 RCTs (10,040) Higher use of LARC and effective types† for intervention vs comparison (RR, 1.39 [95% CI, 1.16-1.72]; 10 trials [n=5,239]). Consistent; precise Interventions and contraceptives varied across trials; different definitions of effective types High; high
Pregnancy at 12-18 months 5 RCTs (4,333) Lower pregnancy rates for intervention vs comparison in 4 trials; no differences in 1 trial of structured vs routine counseling. Consistent; precise Interventions and contraceptives varied across trials Moderate; moderate
Advance emergency contraception Use at 6-12 months 8 RCTs (6,335) Higher use of emergency contraception for intervention versus comparison (RR, 2.12 [95% CI, 1.79-2.36]; 8 trials [n=4796]). Consistent; precise Some non-US studies High; high
Pregnancy at 6-12 months 3 RCTs (4,053) Lower pregnancy rates in 1 trial of counseling and provision of emergency contraception vs folate but not in 2 trials of provision vs information on how to obtain emergency contraception. Inconsistent; imprecise Few trials with pregnancy outcomes Low; moderate
Immediately postpartum Use at 3-6 months 5 RCTs (864) Higher use of LARC, IUD, implant, effective types, and emergency contraception for intervention vs comparison (RR, 1.15 [95% CI, 1.01-1.52]; 5 trials [n=644]). Consistent; precise Trials enrolled small numbers of participants; interventions and contraceptives varied across trials Moderate; low
Pregnancy at 12 months 1 RCTs (100) No differences in pregnancy rates for enhanced vs routine contraceptive counseling before hospital discharge. NA One small trial with few pregnancies reported Insufficient; insufficient
At time of abortion Use at 3-6 months 5 RCTs (1,626) Higher use of LARC, IUD, and effective types for intervention vs comparison (RR, 1.19 [95% CI, 1.09-1.32]; 5 trials [n=1,117]). Consistent; precise Some trials enrolled small numbers of participants Moderate; moderate
Pregnancy at 6-12 months 2 RCTs (1,323) Lower pregnancy rates with immediate vs delayed IUD insertion and immediate IUD vs 1-year supply of oral contraceptives. Consistent; precise Few trials with pregnancy outcomes Low; low
Pharmacist provided Use at 2-4 months 2 RCTs (574) Higher use of LARC and effective contraception for intervention vs comparison in both trials. Consistent; precise Few trials; non-US studies Low; low
Pregnancy No trials NA NA NA Insufficient; insufficient
To increase continuation Use at 3-12 months 7 RCTs (5,660)

  • Higher use of DMPA with self-injection vs clinic injection in 1 trial.

  • Increased oral contraceptive use with 6-months of text messages in one trial, no differences with text or phone reminders in 2 other trials, or with quick versus conventional start methods (2 trials).

 Inconsistent for oral contraceptives; precise Self-injection was only evaluated in a single trial Low; moderate
Potential harms of contraceptive care
STIs Rates at 3-6 months 5 RCTs (5,859) No differences between intervention vs comparison in 5 trials (RR, 1.05 [95% CI, 0.87-1.25]; 5 trials [n=5,051]). Consistent; precise Self-report may be unreliable Moderate; high
Lack of condom use Condom and dual-use at 6-12 months 6 RCTs (5,384) No differences between intervention vs comparison in 6 trials (RR, 1.03 [95% CI, 0.94-1.13]; 6 trials [n=3,898]). Consistent; precise Self-report may be unreliable Moderate; moderate
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Abbreviations: CI, confidence interval; DMPA, depot medroxyprogesterone acetate; IUD, intrauterine device; LARC, long-acting reversible contraception; aOR, adjusted odds ratio; RCT, randomized controlled trial.

*

The most common limitations include no or unclear descriptions of blinding, high loss to follow-up, and lack of or unclear descriptions of intention-to-treat analysis; additional limitations are listed in the table.

†

Definition of effective types varies by trial.

Trials of the effectiveness of contraceptive counseling and provision interventions consistently showed higher contraceptive use in adolescents and adult women in various clinical settings compared with usual care or active controls, such as educational materials without counseling. In addition, interventions were effective in other more specific settings including the advance provision of emergency contraception, interventions immediately postpartum or at the time of abortion, and when directly provided by pharmacists.

Trials generally indicated fewer pregnancies among women randomized to contraceptive counseling and provision interventions. However, trials used different assumptions or definitions of pregnancy intention or did not differentiate unintended pregnancy from pregnancy in general, follow-up was often incomplete, and results were inconclusive in trials of specific clinical populations, such as postpartum women. Since the efficacy of contraception in preventing pregnancy is well established, the clinical goal of contraceptive counseling and provision is to assist patients desiring contraception to successfully initiate and maintain use. Most of the interventions evaluated in this review met this need by demonstrating higher contraceptive use among the intervention group participants. Trials of potential harms of counseling and provision interventions indicated no evidence of difference in STI rates or condom use compared with usual care. Additional harms, including anxiety, stigma, and reproductive coercion were not evaluated in trials.

Although no previous systematic reviews of contraceptive care included the same target population, key questions, and interventions as this review, results are generally consistent with other reviews of contraceptive counseling interventions and advance provision of emergency contraception (71-76).

Based on the number, quality, and size of trials; consistency of results between trials; and directness of evidence, the strength of evidence grade meets criteria for high for the effectiveness of interventions to increase use in clinical settings and for provision of advanced emergency contraception. Strength of evidence is moderate for interventions provided immediately postpartum and at the time of abortion; and low for interventions by pharmacists and to increase adherence largely due to the limited number and size of these studies. For pregnancy outcomes, strength of evidence ranges from insufficient to moderate based on available trials. The strength of evidence for lack of potential harms of contraceptive care interventions is moderate for STIs and condom use. Collectively, applicability is moderate to high based on the large numbers of trials and participants enrolled from a variety of clinical practice settings, although it is lower for outcomes with few trials.

Limitations of this review include using only English-language articles and studies applicable to the United States, although this focus improves its relevance to clinical practice in U.S. settings. This review is also subject to publication bias in which studies with negative or null findings are not included because they were never published, although the analysis demonstrated no evidence of small study effects suggesting no publication bias for interventions with enough trials to evaluate. Many additional questions critical to contraceptive care fall outside the scope of this review which focuses on health outcomes of contraceptive care clinical service interventions. A wide range of issues concerning contraception and the impacts of unintended pregnancy were not addressed.

Few effectiveness trials were designed or powered to determine unintended pregnancy outcomes. Interventions and types of contraceptives differed across trials. Important harms beyond STIs and lack of condom use were not evaluated. Several trials enrolled small numbers of participants, lacked blinding or did not describe blinding methods, or had high loss to follow-up or attrition. Meta-analysis for the systematic review used outcomes from the most common follow-up times in trials when loss to follow-up was minimal, most frequently 3 to 6 months for contraceptive use measures, although longer time periods are also clinically relevant. Trials based in specific healthcare systems or settings may not be relevant to others, particularly small trials with highly tailored interventions.

Future research should further evaluate approaches to contraceptive counseling and provision that strengthen and expand the findings of this review. Gaps remain in determining best practices, particularly for medically high-risk populations and those with limited access to care. In addition, research is needed to refine measures related to pregnancy intention (77) and planning; create uniform definitions of contraceptive care, interventions, measures of use, and outcomes; evaluate interventions in additional patient populations and settings; and develop culturally appropriate contraceptive care models and interventions for specific populations including transgender and non-binary patients (78, 79).

Research on contraceptive care also requires continuous calibration with cultural and societal contexts. Current research priorities include an emphasis on shared decision making; use of new technology, including electronic patient decision support tools; innovations in service delivery (80); and the influence of federal and state policies on payment and access. An equity framework that focuses on person-centered care and access to a broad range of contraceptives, rather than promoting select contraceptive methods, is now encouraged by researchers in the field (81, 82).

In conclusion, trials of contraceptive counseling and provision interventions that provide services for women beyond usual care increase contraceptive use without increasing STIs or reducing condom use. Clinicians and health systems could improve contraceptive care by providing effective services applicable to their patient populations. These include implementing enhanced contraceptive counseling, provision, and follow-up services; providing emergency contraception in advance; and delivering services immediately postpartum or at the time of abortion.

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Resources Legacy Fund Grant #14338

Additional Funding Source:

NLM T15LM007088

Appendix

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Footnotes

Publisher's Disclaimer: This is the prepublication, author-produced version of a manuscript accepted for publication in Annals of Internal Medicine. This version does not include post acceptance editing and formatting. The American College of Physicians, the publisher of Annals of Internal Medicine, is not responsible for the content or presentation of the author-produced, accepted version of the manuscript or any version that a third party derives from it. Readers who wish to access the definitive published version of this manuscript and any ancillary material related to this manuscript (e.g., correspondence, corrections, editorials, linked articles) should go to Annals.org) or to the print issue in which the article appears. Those who cite this manuscript should cite the published version, as it is the official version of record.

Reproducible Research Statement:

Study protocol: Available from PROSPERO CRD42020192981 (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=192981 )

Statistical code: Statistical code for the meta-analysis is available from investigators.

Data set: Data for the meta-analysis are available from investigators.

Additional Contributions: We gratefully acknowledge members of the stakeholder and advisory panels for their contributions to this project.

Disclaimer: The findings and conclusions in this document are those of the authors, who are responsible for its content.

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