Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
調査の概要
詳細な説明
This study will recruit HIV-negative adolescents girls (AG) aged 15-19 years in Siaya County, western Kenya. The study will evaluate the impact of the provision of oral HIV self-testing on uptake of testing among partners of adolescent girls. We will randomize about 300 sexually active AG to either an intervention group that receives multiple oral self-test kits that they can choose to offer to their sexual partner(s) or to a control group that will be given multiple referral coupons that their partners can use for HIV testing at pre-selected HIV testing services (HTS) sites. We will collect data on whether the kits were offered, to whom they were offered, if they were accepted, if they were used and with what results, if known, and if the partners who obtained HIV-positive results sought confirmatory testing. We will also conduct in-depth interviews with a sub-set adolescents to explore their experiences in offering HIV self-testing to their male partners.
This study has 4 specific aims: i) determine whether adolescent girls can safely offer oral HIV self-tests to their partners; ii) assess whether oral self-testing improves uptake of HIV testing among partners of adolescent girls; iii) document adverse events associated with offering oral self-testing to sexual partners of adolescent girls; and iv) qualitatively explore the experiences of adolescent girls when offering self-test kits to their partners.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Kisumu、ケニア
- Impact Research & Development Organization
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Female
- Aged 15-19 years
- HIV-negative (willing to self-test onsite in the presence of the Research Assistant who is also a trained HIV counselor)
- Has at least one current sexual partner she expects to meet at least twice in the next 3 months (not necessarily to have sex); this will provide opportunity for the participant to suggest/offer testing.
- Resides in Siaya County and does not intend to relocate within 6 months from enrollment, to allow follow up to be completed and to conduct IDI with those selected.
- Willing to be randomized into the partner self-testing or HTS referral groups.
- Reporting no incident of sexual, physical, emotional, or economic abuse in the last 12 months from the partner she intends to offer (Appendix 4) or refer for testing (Appendix 3) in the next 3 months and does not believe the partner will abuse her if she offers the self-test kits or HTS referral coupon.
- Has a male partner who has not tested for 6 months or whose HIV status is unknown to her.
- Agrees to give consent to participate in the study.
Exclusion Criteria:
- Male
- HIV-positive
- Not willing to self-test onsite under in the presence of the Research Assistant
- Aged <15 years or >19 years
- Does not have a current sexual partner or does not expect to meet the partner at least twice in the next 3 months
- Does not reside in Siaya County or intends to relocate within the next 6 months
- Not interested in obtaining HIV self-tests or HTS referral coupon for purposes of suggesting testing to their sexual partners
- Reporting an incidence of sexual, physical, emotional or economic abuse in the last 12 months from the partner she would have offered self-test kit or referred for testing, or believes the partner may subject her to sexual, physical, emotional, or economic abuse if she offered them self-test kit or HTS coupon.
- Has a male partner who tested within the last 6 months.
- Does not give consent to participate in the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Provision of multiple self-tests
Participants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s).
The participant will be instructed to encourage their partner to test himself alone [partner testing] or with the participant [couple testing]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing.
All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information
|
Participants will be given multiple Oraquick Advance HIV-1/2 test kits to distribute to their sexual partners for partner testing or couple testing.
Phone interviews will be conducted with the participants to assess whether they provided a HIV self-test to their partner, if the test was used, how it was used (partner testing or couple testing), if the partner disclosed his results, the partner's reaction to the results, and if the partner went for confirmatory testing
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|
介入なし：Referral vouchers for clinic testing
Participants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites.
The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone [partner testing] or together with the participant [couple testing].
The coupon will also have information on testing and a list of facilities where he can go for HTS.
All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
uptake of partner HIV testing
時間枠：3 months
|
proportion of partners that complete HIV testing
|
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Introduce testing
時間枠：3 months
|
proportion of participants who introduce testing to their partners
|
3 months
|
|
Partner accept testing
時間枠：3 months
|
proportion of partners who were offered HIVST or referral coupon and accepted
|
3 months
|
|
Partner testing
時間枠：3 months
|
proportion of participants who report their partner tested alone
|
3 months
|
|
Couples testing
時間枠：3 months
|
proportion of participants who report testing with their partner
|
3 months
|
|
Positive partner
時間枠：3 months
|
proportion of participants who report their partner test result was positive
|
3 months
|
|
linked to care
時間枠：3 months
|
Proportion of participants who report their partners was linked to care
|
3 months
|
|
Intimate partner violence
時間枠：3 months
|
proportion of participants in each study group who report intimate partner violence related to HIV testing
|
3 months
|
|
Confirmatory testing for positive HIV self-test
時間枠：3 months
|
proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing
|
3 months
|
協力者と研究者
捜査官
- 主任研究者：Kawango Agot, PhD、Impact Organization & Research Development
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 848410
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